Download as pdf or txt
Download as pdf or txt
You are on page 1of 32

Department of Health Research

Ministry of Health and Family Welfare, Government of India

SPECIAL EDITION ON
PAEDIATRIC AND
EXTRAPULMONARY TUBERCULOSIS

PARTNER

Central TB Division
Ministry of Health and Family Welfare
Government of India
Suggested Citation: Standard Treatment
Workflows of India, 2022, Special Edition on
Paediatric and Extrapulmonary Tuberculosis,
Indian Council of Medical Research, Department of
Health Research, Ministry of Health and Family
Welfare, Government of India

©ICMR

All rights reserved. No part of these workflows may


be transmitted or reproduced in any form or by any
means without prior permission from the
organization.

Printed in India
of India

Special Edition on
Paediatric and
Extrapulmonary Tuberculosis
Department of Health Research
Ministry of Health and Family Welfare, Government of India

These STWs have been prepared by national experts of India with


feasibility considerations for various levels of healthcare system in
the country. These broad guidelines are advisory, and are based on
expert opinions and available scientific evidence. There may be
variations in the management of an individual patient based on
his/her specific condition, as decided by the treating physician.
There will be no indemnity for direct or indirect consequences.
Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health
Research, Ministry of Health & Family Welfare, Government of India.
Department of Health Research
Ministry of Health and Family Welfare, Government of India

• INTRODUCTION
• SPECIALITIES COVERED IN THIS EDITION
Paediatric Tuberculosis
Paediatric Abdominal Tuberculosis
Paediatric Intrathoracic Tuberculosis
Paediatric Lymph node Tuberculosis
Paediatric Osteoarticular Tuberculosis
Paediatric Tubercular Meningitis

Adult Extrapulmonary Tuberculosis


Adult Abdominal Tuberculosis
Adult Lymph Node Tuberculosis
Adult Musculoskeletal Tuberculosis
Adult Pericardial Tuberculosis
Adult Pleural Tuberculosis
Adult Tubercular Meningitis
Cutaneous Tuberculosis
Female Genital Tuberculosis
Genitourinary Tuberculosis
Intraocular Tuberculosis

Investigations & Treatment


Microbiological Workup for Adult Extrapulmonary TB
ATT Drug Dosages
ATT Hepatitis

• CONTRIBUTORS
INTRODUCTION Department of Health Research

GOAL
Ministry of Health and Family Welfare, Government of India

To empower the primary, secondary and tertiary care


physicians/surgeons of all specialties towards achieving the goal
of TB elimination by increasing detection of Paediatric TB and
Extrapulmonary TB with disease management protocols and
pre-defined referral mechanisms.

OBJECTIVES
• To formulate comprehensive algorithms for detection and
management of Paediatric and Extrapulmonary TB at primary,
secondary and tertiary level health care system
• To improve implementation of the National TB Elimination
Programme guide lines by doctors working in peripheral health
care and also guide the National Programme to put resources
optimally for the management of these conditions
METHODOLOGY COMMITTEE

EDITORIAL
EDITORIAL BOARD
COMMITTEE
DESIGN TEAM

ICMR STW TEAM ICMR TB UNIT

EXPERT GROUPS COMMITTEES

PROCESS OVERVIEW

DEVELOP STWS • 16 Meetings


& • Participation also from
CONVERT THEM Public Health Specialists
INTO Search Strategists
TOPIC INFOGRAPHICS Clinical Scientists
PRIORITIZATION Graphic Designers

• Prevalence studies
• Global burden of
diseases studies REVIEW OF
• HBP of AB-PMJAY CURRENT • Review by Editorial Committee
• Existing guidelines GUIDELINES &
FEASIBILITY AS
PER HEALTH
SYSTEM
Paediatric Tuberculosis
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


PAEDIATRIC ABDOMINAL TUBERCULOSIS
ICD-10-A18.31
WHEN TO SUSPECT? CLINICAL FEATURES SPECIFIC TO TYPE OF ABDOMINAL TB EXAMINATION FINDINGS
• One or more of following PERITONEAL TB VISCERAL TB (LIVER, • Anthropometry
• Abdominal pain, distension
› Recurrent/chronic SPLEEN, PANCREAS) • General physical & systemic
abdominal pain in presence • Fever examination
• Weight loss • Abdominal pain • Look for peripheral LAP,
of red flag signs ascites, hepatosplenomegaly,
› Abdominal distension/mass NODAL TB • Fever doughy feel of abdomen,
› Altered bowel habits • Pain abdomen • Jaundice palpable abdominal lump,
• Fever • Weight loss visible peristalsis or a moving
• Constitutional symptoms like mass -"gola" formation due
• Palpable abdominal lump
Presence of Fever >2 weeks, • Anorexia to partially obstructed
Anorexia, Unexplained weight INTESTINAL TB • Hepatomegaly dilated bowel loop
loss or no weight gain in last 3 • Recurrent intestinal colic
months despite adequate • Altered bowel habits • Splenomegaly RED FLAGS
• Chronic diarrhoea • Hepatic abscess • Pain abdomen waking child
nutrition may be present from sleep
• History of contact with TB • Partial/complete intestinal • Palpable • Chronic, severe, or nocturnal
patient may also be present obstruction abdominal lump diarrhea
• Weight loss, anorexia • Presence of constitutional
• Abnormal LFTs symptoms like fever,
• Palpable abdominal lump
• Lower gastrointestinal anorexia, weight loss, etc.
• Localized distension or mass
bleeding

INVESTIGATIONS
ESSENTIAL Ascites Intestinal involvement
• Ultrasound abdomen Essential Desirable
SUGGESTIVE FINDINGS NON SPECIFIC FINDINGS • If exudative ascites, ascitic fluid • CECT Abdomen/CT enterography
• Abdominal LN : • Intraabdominal fluid for NAAT, TB culture • USG guided Abdominal Mass -FNA for
measuring >15 mm in (free or loculated) or • No role of ADA
short axis, conglomerate Inter-loop ascites cytology, NAAT, culture
and/or central necrosis • Ascitic fluid with Enlarged Abdominal mass
• Omental/mesenteric multiple septations Optional
thickening >15 mm with • Abdominal LAP with Desirable
increased echogenicity SAD <15 mm in • Ileocolonoscopy, tissue biopsy (HPE, NAAT)
absence of red flag • USG guided Abdominal • Laparoscopy, tissue biopsy for HPE, NAAT
• Ileocaecal wall
thickening signs mass-FNA for cytology, NAAT, TB
• Chest X Ray culture
• sputum/GA/IS (If CXR abnormal) for NAAT, TB culture Optional
• Ascitic fluid (If present) for cytology, protein & albumin • USG/CT guided core biopsy of LN
• Peripheral LN-FNA (If size >2 cm) for cytology, NAAT, TB
culture for histology, NAAT, TB culture

DIAGNOSTIC ALGORITHM
If abdominal TB suspected

Look for peripheral nodes, get CXR and Abdominal USG

USG suggestive of TB USG normal

Evaluate for other causes/


CXR abnormal Peripheral nodes + No peripheral nodes CXR Normal Refer to higher centre

Sputum/GA/IS for NAAT/TB FNA for NAAT/TB Lymphadenopathy or Ileocecal TB*


Ascites
culture culture/Cytopathology abdominal mass
Ascitic fluid aspiration - FNA for NAAT/TB CECT Abdomen/CT
Positive Negative* Positive Negative* Cytology, protein, sugar culture/Cytopathology* enterography#
where feasible
If Exudative with lymphocytic predominance,
Start treatment Start treatment ascitic fluid for NAAT/TB culture
Positive

*Consider USG guided FNA from abdominal nodes/ refer to higher centre if not available or feasible
Positive
#Consider CECT Abdomen/CT enterography if Isolated ileocaecal thickening or LN sampling not Start treatment
feasible/Refer to higher centre if not available Start treatment

MANAGEMENT
TREATMENT MONITORING WHEN TO REFER?
• Start treatment & follow-up as per NTEP • Assessment of response to treatment:
› Clinical follow up - every month during • Diagnosis is uncertain &
• ATT for 6 months (2HRZE + 4HRE)
treatment & after that every 3 months additional
• Pyridoxine supplementation- 10 mg/day
› Radiologically by USG - At the end of investigations are
• Steroids- Routinely not recommended (SAIO)
treatment or if worsening or non response to required
• Supportive treatment- Management of treatment
SAM/Malnutrition as per national guidelines › Microbiological - If worsening or non • Acute intestinal
• Surgical treatment: response to treatment obstruction or bowel
› Acute intestinal obstruction, Bowel • Pointers towards DR TB investigation: perforation
perforation › Non response to treatment or Worsening or • DR TB
› Persistence of obstructive symptoms deterioration of constitutional symptoms
despite conservative management & ATT
after initial improvement. Rule out Crohn's • No response to
disease OR Inflammatory Bowel Disease appropriate treatment
• DO NOT start Empirical ATT with isolated: • Obstructive symptoms may persist or worsen
› Recurrent/Chronic abdominal pain without despite treatment with appropriate ATT • Oral drug (ATT)
• Monitor for
red flag signs intolerance/cannot be
› Adherence to treatment (ATT)
› Chronic diarrhoea without proper evaluation › Adverse drug reactions- ATT induced given
› Failure to gain weight
ABBREVIATIONS
ATT- Antitubercular treatment E- Ethambutol IS- Induced Sputum R- Rifampicin
CECT- Contrast Enhanced Computed Tomography FNA- Fine Needle Aspiration LAP- Lymphadenopathy SAD- Sagittal Abdominal Diameter
GA- Gastric Aspirate SAIO- Sub Acute Intestinal Obstruction
CT- Computed Tomography LN- Lymph Node
H- Isoniazid SAM- Severe Acute Malnutrition
CXR- Chest X-Ray HPE- Histopathological Examination MGIT- Mycobacteria Growth Indicator Tube
USG- Ultrasonography
DR-TB- Drug Resistant tuberculosis IBD-Inflammatory Bowel Disease NAAT- Nucleic Acid Amplification Test Z- Pyrazinamide

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India.
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 10 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare, Government of India accessed at
https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 10 March, 2022.
This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


PAEDIATRIC INTRATHORACIC TUBERCULOSIS
(PULMONARY, PLEURAL, MEDIASTINAL)
ICD-10-A15
Documented, persistent unex- EXAMINATION
plained fever for 2 weeks or more
• Temperature, Weight, Mid Arm Circumference (MAC), Lymphadenopathy, cold abscess, discharging sinus
• Chest examination findings depend upon underlying pathology like consolidation, pleural effusion etc.
Unremitting cough for
2 weeks or more INVESTIGATIONS
Essential Desirable
Unexplained docu- • Chest x-ray of family members
• Chest x-ray
mented weight loss
› TB suggestive: Hilar/ paratracheal lymph
of ≥ 5% in last 3
months
nodes, fibrocavitory disease, Miliary pattern Fibrocavitary shadows Optional (to be done in institutions)
› Non Specific : effusion, consolidation,
Suggestive of TB
• CECT scan
WHEN TO bronchopneumonia, other shadows etc. • Pleural Biopsy
No weight gain • Image guided (USG/CT)
SUSPECT? despite adequate
• Sputum/Induced Sputum/Gastric Lavage/ mediastinal LN biopsy
Aspirate /pleural fluid for NAAT • Bronchoscopy & BAL
nutrition Miliary Shadows
• Smear examination (if NAAT unavailable) Suggestive of TB

Unexplained loss of • If facilities exist, send aliquot of sample for


appetite culture, if NAAT negative for MTB DO NOT DO
• Pleural tap**: Gross, Cytology, Biochemistry, • TST/Mantoux test
NAAT, MGIT/LJ, ZN if NAAT not available Hilar LN enlargement › Overemphasized, supportive
Chest pain (specific to Suggestive of TB
only
If can’t be done at primary level then refer
**
pleural effusion) › Not to diagnose TB or to start
ATT on basis of +ve TST ONLY
Contact with TB patients in past • Serological tests- IGRA
2 years Do HIV testing for all cases with TB (Quantiferon/Quantiferon-Gold etc)
Paratracheal LN Suggestive
• Pleural fluid ADA
of TB

DIAGNOSTIC ALGORITHM
ALGORITHM FOR PEDIATRIC INTRATHORACIC TB AMONG CHILDREN WITH NO RISK FACTORS FOR DRUG RESISTANCE
PEDIATRIC TB FURTHER WORK-UP ALGORITHM UNDER U-DST
• Persistent Fever ≥2weeks, without a known cause and/or
• Unremitting cough for ≥2weeks and/or Presumed TB NAAT
• Weight loss ≥5%; or no weight gain in past 3 months despite adequate nutrition; or cases
failure of nutritional rehabilitation in babies with SAM
• With or without contact with patient with Pulmonary TB in past 2 years MTB +ve
MTB -ve
Clinically diagnosed
Chest X-ray TB case with no risk Rif resistance -ve Rif resistance +ve$
CXR Normal
factors for DRTB
CXR suggestive CXR Non specific shadows Pleural Effusion FL-LPA
Repeat NAAT SL - LPA*
• Check for EPTB
Pleural fluid for NAAT, Treat with
Sputum/GA/IS for Give antibiotics (Amoxyclav cytology, biochemistry • Needs detailed Reinvestigate
& Sputum/GA/IS for investigation for TB/ standard Rif resistance -ve
approved NAAT for or Amoxicillin & avoid regime for nonresponse
MTB quinolones, linezolid) NAAT for MTB alternate diagnosis.
Skip if already taken May need CECT 2HRZE/4RHE including for
MTB +ve MTB -ve chest / other DRTB
investigations as per Add Pyridoxine
symptoms 10 mg/day FQ and/or SLI
MTB +ve MTB -ve Persistent shadow & Microbiologically
symptoms No response Resistance
confirmed TB case • Consider referral to
higher center for in 4 weeks
• Look for significantly enlarged peripheral LN & further H Resistant (inhA and/or
test LN aspirate for MTB investigations KatG mutation)
H Resistant
• Repeat NAAT with good sample/ alternative FL-LPA** Eto resistance (inhA
Not detected
Microbiologically sample (BAL/aspirate) as per feasibility Straw colored, exudative mutation)
confirmed TB case • May seek review from a higher centre effusion
$
RR detected in new case with no risk factors for DRTB needs retesting if only
MTB detected is very low as it makes Rif resistance detection less reliable
No alternative diagnosis
*
SLLPA may be done directly if smear +ve else send for MGIT followed by
MTB MTB -ve or if repeat SLLPA or LC DST (Mfx 2.0, Km, Cm, Lzd)
Rif resistance Rif resistance -ve +ve test not feasible treat as clinically diagnosed **
LPA may be done directly if smear +ve else send for MGIT followed by FLPA
+ve follow Give 1st line ATT probable TB case to evaluate for H (inhA and/ or KatG mutn) and Eto (inhA) resistance
DRTB pathway

TYPE OF PATIENTS TB TREATMENT Number of tablets (dispersible FDCs) • Consider steroids in miliary TB
REGIMENS with hypoxia, Endobronchial
Microbiologically confirmed RS WEIGHT Intensive phase Continuation phase
TB massive bilateral effusion
Pulmonary TB BAND HRZ E HR E with distress
Clinically diagnosed Pulmonary TB 2HRZE + 4HRE 50/75/15 100 50/75 100 • Prednisone dose 2 mg/kg
Drug sensitive previously treated TB 4-7 kg 1 1 1 1 daily or Dexamethasone 0.6
(recurrent, failure, treatment after mg/kg/day for 4 weeks
default)* 8-11 kg 2 2 2 2 • Reduce dose gradually over
*DR TB algorithm-DST next 4 weeks before stopping
12-15 kg 3 3 3 3
ISONIAZID (H) 7-15 mg/kg (maximum dose 300mg/day) • Pyridoxine 10 mg/day for 6
4 4 months
RIFAMPICIN (R) 10-20 mg/kg (maximum dose 600mg/day) 16-24 kg 4 4
• Nutritional support
PYRAZINAMIDE (Z) 30-40 mg/kg (maximum 2000mg/day) 25-29 kg 3 + 1A* 3 3 + 1A* 3
• Treat co-morbid conditions:
ETHAMBUTOL (E) 15-25 mg/kg (maximum 1500mg/day) 30-39 kg 2 + 2A* 2 2 + 2A* 2 HIV, SAM
*A=Adult FDC (HRZE = 75/150/400/275; HRE = 75/150/275)

When to assess MONITORING MANAGING TREATMENT INTERRUPTIONS (NON-ADHERENCE)


ABBREVIATIONS
• Within 2 weeks of starting therapy for checking that- correct dose, combination of drugs is
being taken, adherence and tolerance to drugs Interruption up to 4 weeks Interruption over 4 weeks
• Then every month till completion of treatment
What to assess Resume therapy
Reinvestigate for DRTB
• Appropriateness of therapy: (Restart if missed within 1st 4 weeks)
• Correct combination, acceptance/tolerance
• Counsel about need to complete & not miss on doses (Inform, if doses are missed) Rif resistance not detected Rif resistance detected
• Response to therapy:
• Clinical (symptoms, adverse effects, weight, dose revision)
• X-ray at end of therapy Retreat with 1st line drugs and Treat as MDRTB
• Do X-ray for worsening at any time OR slow resolution OR persistent symptoms at end of IP Check for INH resistance and treat
• NAAT is not appropriate follow up tool for monitoring progress of disease • In case interruption happens in CP & on retrieval, the patient has
• Smear examination at end of treatment (to declare outcome) no clinical evidence of active disease & tests for DRTB are
• Repeat microbiological test (smear, MGIT, NAAT) at end of IP & at end of therapy, if still
symptomatic or any deterioration/failure to respond
negative, the remaining treatment course to be completed
• Resons for interruption should always be evaluated & addressed
• After treatment completion: follow up patients clinically at end of 6, 12, 18 & 24 months in all cases (Address myths/fear or any intolerance)
ABBREVIATIONS
ADA: Adenosine Deaminase DRTB: Drug resistant TB FQ: Fluoroquinolones IS: Induced sputum RIF: Rifampicin
BAL: Broncho-alveolar lavage DST: Drug sensitivity test GA: Gastric aspirate LN: Lymph node SAM: Severe acute malnutrition
CBNAAT: Cartidge-based Nucleic Acid EPTB: Extra-pulmonary TB H: Isoniazid MAC: Mid Arm Circumference SLI: Second line injectables
Amplification test ETO: Ethionamide HIV: Human Immunodeficiency virus MTB: Mycobacterium Tuberculosis SL-LPA: Second line - Line probe assay
CECT: Contrast enhanced CT FDC: Fixed dose combination HRZE: Isoniazid; Rifampicin; Pyrazinamide; Ethambutol NAAT: Nucleic acid amplification test TST: Tuberculin skin test
CP: Continuation phase FL-LPA: First line - Line probe assay IGRA: Interferon Gamma Release assay PPD: Purified Protein Derivative USG: Ultrasonography
CT: Computed tomography ZN: Ziehl Neelson

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme managers & Medical Officers. Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 06 March, 2022.
2. Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India March 2021. National TB elimination programme, Central TB Division, Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 06 March, 2022.
This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


PAEDIATRIC LYMPH NODE TUBERCULOSIS
ICD-10-A18.2

WHEN TO SUSPECT? INVESTIGATIONS


• Persistent enlargement of lymph node for >2 Essential
weeks in one or more areas in cervical/axillary • Lymphnode aspirate:
/inguinal regions
› Size > 2 cm or matted lymph nodes ± chronic › Send for NAAT (also MGIT culture,
sinus particularly if the patient is at risk of DRTB)
• With/without associated systemic symptoms: › Smear for AFB
fever, cough, poor appetite, weight loss
• With no evidence of recent scalp/skin lesions of Desirable
draining area • Lymphnode cytopathology (If NAAT and smear
• Cold abscess / chronically discharging sinus over negative)
neck, axilla, or groin • Lymphnode Biopsy (Core/Excision)
TB is unlikely if: the lymphnodes are • Chest X-ray - should particularly be done if FNAC
small (< 2 cm) AND are persisting for a not possible
long time (months to years) without • Hemogram with peripheral smear
any systemic symptoms
• Cytopathology

DIAGNOSTIC
Peripheral Lymph node > 2cm in one or more sites

Look if

CHEST X-RAY MATTED LN/COLD ABSCESS/SINUS

Yes No
If chest x-ray abnormal: Get No • Aspirate pus from sinus or pus from Antibiotics Amoxycillin/ Amoxycillin-
Sputum /Induced sputum/GA fluctuating lymph node. Clavulanate are recommended (Avoid
for NAAT and AFB Linezolid & quinolones)
• If no pus, do FNAC
• Send for NAAT, AFB smear, Cytopathology Review after 2
No weeks
• Send MGIT particularly if DRTB suspected
If no response
Mtb or AFB detected

AFB detected on smear and/or Mtb Excision/core biopsy if facility


Yes detected on NAAT and/or suggestive No available and send for NAAT, AFB
cytopathology like caseation or smear, histopathology & TB culture
Yes
epitheloid granuloma present
Choose appropriate Yes Any of these positive AFB on smear/ positive NAAT/caseous
regiment for DSTB vs granuloma
DRTB based on NAAT No
result
Refer or investigate appropriately.
Excision Biopsy may be needed.

TREATMENT AND MANAGEMENT


TREATMENT AND RESPONSE WHEN TO REFER TO AN EXPERT?
• Treatment should be started and follow-up should be • Diagnosis is not established with FNAC/NAAT
conducted as per NTEP guidelines • Surgical facility is not available to do excision or core
• Treat with 2 HRZE + 4 HRE (standard doses) if new case & biopsy
RIfampicin resistance not detected or not known • DR is suspected due to any reason including
• If retreatment case or any other risk factor for DRTB, detailed & non-response and the facility for DRTB testing are not
swift investigations for DRTB are advised before starting available
treatment • If there is any pointer
• towards possible malignancy e.g.
skin or mucosal bleed or significant pallor or generalised
• Disappearance of constitutional symptoms with decrement or adenopathy irrespective of the size or associated
no increment in lymph node size suggests response to hepato-splenomegaly
treatment
• Increment in lymph node size with disappearance of
constitutional symptoms may suggest paradoxical reaction, BCG LYMPHADENITIS
provided drug resistance has been ruled out • Age is usually < 2 years
• Increment in lymph node size without disappearance of • Axillary and or supraclavicular lymphnode on the same
constitutional symptoms suggests drug resistant TB/alternate side as BCG vaccination (usually given on the left)
cause • No systemic symptoms in immunocompetent children
• Do not treat for TB based on only positive • Treatment:
mantoux test or FNAC suggestive of reactive • Wait and watch if small
lymph node with negative NAAT/AFB on smear • If large and suppurative, repeated aspiration or rarely
• Children with disappearance of constitutional incision and drainage is required
symptoms with no increase in lymphnode size at *NAAT or AFB smear positivity can not differentiate between
the end of 6 months therapy, can be kept on BCG and MTB
follow-up with no extension of therapy

ABBREVIATIONS
NAAT: Nucleic acid amplification test
AFB: Acid fast bacillus FNAC: Fine needle aspiration cytology
BCG: Bacille Calmette Guerin vaccine NTEP: National TB Elimination Programmet
HRZE: Isoniazid; Rifampicin; Pyrazinamide; Ethambutol
DR: Drug resistant TB: Tuberculosis
MGIT: Mycobacteria Growth Indicator Tube

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training modules for programme managers & Medical officers. Ministry of Health and Family Welfare, Government of India accessed at
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 on 24 February, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB elimination programme, Central TB division, Ministry of Health and Family Welfare,
Government of India accessed at https://tbcindia.gov.in/showfile.php?lid=3590 on 10 February, 2022.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


PAEDIATRIC OSTEOARTICULAR TUBERCULOSIS
ICD-10-18.0
POTTʼS SPINE DACTYLITIS ARTHRITIS
(COMMONEST, 50% OF OSTEOARTICULAR TB) (SHORT BONES) (LARGE JOINTS-HIP/KNEE COMMONEST)
• Insidious onset back pain for >6 weeks • Swelling of short tubular bones of
WHEN TO SUSPECT

• Insidious onset joint pain, swelling


(Commonest thoracic > lumbar >cervical) hands & feet (Proximal phalanx or
• Localized/Referred root pain metacarpals of index/middle/ring • Monoarticular arthritis
• TB Symptoms: Fever/anorexia/weight loss fingers are commonly affected) • Commonly associated with
• CNS complications like Paraparesis pulmonary or lymph node TB
• In children multiple or consecutive •
(20-50%), cauda equina syndrome, bones are involved, compared to a
paraspinal muscle wasting, severe pain single bone in adults
• Examination: Local tenderness/Gibbus-
Neurological abnormality like exaggerated • May present without pyrexia or signs
DTRs or deficit may be present of inflammation
ESSENTIAL ESSENTIAL ESSENTIAL
• X-ray Spine • Plain X-ray of involved parts • X-ray of the invovlved joint(s): A triad of
› In early stage X-ray may be normal › Diaphyseal expansile lesion X-ray abnormalities (Phemister's triad)
› May show end plate erosions, joint space › Periosteal reaction is uncommon may be seen
narrowing/collapse, decreased vertebral › Healing is by sclerosis (usually › Peri-articular osteoporosis
height, paravertebral soft tissue shadow gradual) › Peripherally located osseous erosion
INVESTIGATION

• MRI Spine preferred, if not feasible do CT › Gradual joint space narrowing


› Marrow edema • X-ray film of chest • Early stage synovitis & arthritis imaging
› Destruction of intervertebral disc, › Sputum/GA for NAAT & MGIT/LJ, if may show wide joint space due to effusion
adjacent vertebral bodies & opposing CXR abnormal
• Bony ankylosis development is rare in TB
end plates arthritis in contrast to Pyogenic arthritis
• FNAC (if peripheral lymphnodes
› Pre/para vertebral or epidural abscess
enlarged) for Cytology, NAAT & • USG/ MRI of joint
• Sputum/GA for NAAT, MGIT/LJ (if CXR
MGIT/LJ • X-ray film of chest
abnormal)
• FNAC (if peripheral lymphnodes enlarged) • GA/Sputum for CBNAAT, MGIT(if CXR
DESIRABLE abnormal)
for Cytology, NAAT & MGIT/LJ
• Image guided (USG/CT) aspirate from • FNAC (if peripheral lymphnodes
DESIRABLE involved bones for NAAT & MGIT/LJ. enlarged) for Cytology, NAAT & MGIT/LJ
• Image guided (USG/CT) aspiration of
DESIRABLE
abscess (if feasible) for NAAT & MGIT/LJ.
• Image guided (USG/CT) aspirate from
joint fluid for NAAT & MGIT/LJ.

DIAGNOSTIC ALGORITHM
BOX B: Clinical manifestation of Spinal TB (STB) /TB arthritis (TBA)
BOX A: Risk factors for TB • Insidious onset back pain for >6 weeks (STB)
• Contact history with TB case • Spine deformity/Kyphoscoliosis/Gibbus/Paraplegia/Sensory loss/Autonomic
• Immunocompromised dysfunction (STB)
• HIV • Insidious onset pain and swelling in joints for >6 weeks (TBA)
• TB Symptoms: Persistent
• Fever, Anorexia, Weight loss (>5% in last 3 months)

• •
Suspect if symptoms of STB/TBA present with/without constitutional symptoms of TB (Box B) and/or risk factors of TB

• X-ray of Spine (AP/Lateral): May show end plate erosions, narrow


/collapsed joint space, reduced vertebral height, paravertebral • MRI Spine(100% sensitive): indicated in all cases: may show
soft tissue shadow. Early stage X-ray may be normal › Marrow edema
• X-ray joints (AP/Lateral): Erosions, sclerosis, calcification or › Destruction of intervertebral disc, adjacent vertebral bodies &
narrow joint space opposing end plates
• USG abdomen for Iliopsoas Abscess › Prevertebral, paravertebral and/or epidural abscesses
• USG joints for joint effusion and diagnostic aspiration • MRI Joints: Synovial proliferation with periarticular picture s/o TBA
• Chest X-ray, ESR, blood sugar, HIV

• Radiological findings s/o osteoarticular TB and/or TB at additional site- can be labeled as clinically diagnosed
Osteoarticular TB
• Refer patients to higher centre for biopsy (Percutaneous CT-guided biopsy-preferred or open biopsy) of lesion for
cytopathology/ biopsy to confirm diagnosis & DST and to rule out other diseases. (Laboratory confirmed osteoarticular
TB) (Risks and benefits of obtaining a biopsy must be considered)

MANAGEMENT
TREATMENT & MONTORING WHEN TO REFER
• Start treatment for microbiologically /Lab confirmed TB and probable TB • Suspected osteoarticular disease if essential investigations are not
• Regimen : 2HRZE + 10HRE (Standard doses) + Pyridoxine 10 mg/day available
• Follow up every month during treatment & subsequently every 3 months: Pott’s • Diagnosis (microbiological or probable) not established by investigations
spine with X-ray or MRI & Tubercular dactylitis or arthritis with plain X-ray • Surgery needed: imaging suggest compressive myelopathy, motor deficits
• Monitor on each visit :
• No improvement with appropriate treatment
a. Symptomatic improvement, weight gain, side effects of medicines
• DR TB : diagnosed or high suspiscion
b. Microbiology : sputum/GA if CXR abnormal at end of IP. Site samples like
aspiration of pus from lesions including psoas abscess (if worsening of Confirm microbiologically in all cases, if possible, before ATT
symptoms/poor response)
• Imaging: MRI/CT/X ray of affected parts: at end of treatment or early if worsening OTHER INFORMATION
• In case of synovial fluid or cold abscess aspiration (against gravity), send
Surgical Indications in Potts Spine
samples for confirmation of TB in following 3 ways
• Progressive neurological deficit
• Paraplegia of recent onset or severe paraplegia › Two dry slide for demonstration of AFB (ZN staining)
• Persistent pain with spinal instability › Two samples in formalin for histopathological examination
• Spinal deformity-severe kyphotic deformity at presentation, or in › Two samples in saline for culture* followed by DST and/or NAAT
children (<10 years of age) at high risk of progression of kyphosis with • Confirmed cases to undergo HIV/blood sugar testing/parent counselling
growth after healing of disease *
MGIT/LJ (if MGIT not available)

DST: Drug Sensitivity Test


ABBREVIATIONS
AFB: Acid fast bacillus HRZE: Isoniazid; Rifampicin; Pyrazinamide; Ethambutol NAAT: Nucleic Acid Amplification Test
AP: Antero-Posterior ESR: Erythrocyte Sedimentation Rate IP: Intensive Phase s/o: Suggestive of
FNAC: Fine Needle Aspiration Cytology STB: Spinal TB
CT: Computed Tomography LJ: Lowenstein Jensen TBA: TB Arthritis
CXR: Chest X-ray GA: Gastric Aspirate MGIT: Mycobacteria Growth Indicator Tube USG: Ultrasonography
DR: Drug Resistant TB HIV: Human Immunodeficiency Virus MRI: Magnetic Resonance Imaging ZN: Ziehl Neelson

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India.
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 12 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare, Government of India
accessed at https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 12 March, 2022.
3. Sharma SK, Ryan H, Khaparde S, Sachdeva KS, Singh AD, Mohan A, et al., Index-TB guidelines: guidelines on extrapulmonary tuberculosis for India, Indian J Med Res. 2017;145(4):448–6
This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


PAEDIATRIC TUBERCULAR MENINGITIS
ICD-10-A17.0
WHEN TO SUSPECT? EXAMINATION INVESTIGATIONS
• Fever with one or • Assessment of Essential NEUROIMAGING IN TB
more of the following sensorium* • CBC
› Headache • Full/bulging anterior • CSF examination
› Vomiting fontanelle › Cell count and differential
› Seizures • Meningeal irritation- › Sugar (with simultaneous blood sugar)
Neck stiffness, Kernig’s › Protein
› Irritability/Lethargy/
Drowsiness sign & Brudzinski’s sign › NAAT*
• Examine eye, if feasible › MGIT culture
› Loss of function e.g.
for papillodema/ › Bacterial culture
recent onset deviation of
eyes/mouth and/or choroid tubercles/ optic • HIV
weakness of arm/leg atrophy • Contrast enhanced CT scan of head
and/or altered mentation • Cranial nerves • CXR
› Malaise, Anorexia, • Motor system including • Gastric lavage/ Induced sputum in
Weight loss power, reflexes plantar patients where CXR is abnormal
responses and CSF NAAT is negative
• Symptoms are usually • Peripheral lymph nodes
*
ICMR/NTEP approved NAAT test, use 3-5 ml
CSF if possible
CECT showing
of 5 to 7 days duration • Chest examination for • Hydrocephalus
with insidious onset, signs of pulmonary Desirable
involvement (ventricular dilatation)
particularly with • MRI brain with contrast when
history of exposure to CECT head is not contributory • Thick basal exudates
infectious TB in past 2 *
Use any standardized scale • Tuberculoma
years including Glasgow Coma Optional
scale/ AVPU scale • CSF cryptococcal antigen
• Contrast CT chest/abdomen to look for
extracranial sites of infection

DIAGNOSTIC ALGORITHM
• Immediate investigations
• CBC, HIV AFB seen/CSF NAAT +ve
• CECT head (Microbiologically
SUSPECTED TBM? • CSF: Cell count including differential, CSF sugar (with
blood sugar), protein, NAAT, bacterial culture confirmed TBM)
• CXR

Criterion 2- Criteria positive if at least 2 Criterion 3


Criterion 1
of the following 3 risk factors are present • Evidence of TB elsewhere
≥3 of the following • HIV infection
• Severe acute malnutrition
• ≥5 days of symptoms as • Recent contact with infectious TB
above
• TLC < 15,000/ cumm
• CSF WBC 10-500/ cumm
2 or more criteria met Yes Start treatment
• CSF sugar < 50% of
blood sugar No
• CSF lymphocytes >50% Continue investigations & management for partially
• Neuroimaging finding treated bacterial meningitis
of (one or more) : IF NOT BETTER
› Basal exudates
• Repeat LP after 48-72 hours
› Hydrocephalus
• Expand search for TB elsewhere
› Infarct
• Consider MRI contrast if not done earlier
› Tuberculoma
Re-review criterion 1, 2 & 3 and see if ≥ 2 criterion fulfilled Yes
No

Continue • Does patient have falling CSF glucose/dropping sensorium?


No • Have new focal deficit? Yes
evaluation

TREATMENT
• Other supportive therapy • Cases should be managed at least at
• Treatment should be started & follow-up a district hospital
to be done as per NTEP guidelines › Care of unconscious child
› Nasogastric feeding, if indicated • Early referral to Medical College/
• Anti TB drug regimen higher centre to be considered if
› 2 HRZE and 10 HRE (in appropriate doses) › Anti edema measures (mannitol/
› Unresponsive child/rapid deterioration
› Pyridoxine 10 mg/day hypertonic saline/glycerol/
indicating need for intensive care
• Corticosteroids acetazolamide)
› No diagnosis after initial evaluation
› Prednisolone 2 mg/kg/day for 4 weeks & › Anticonvulsants, if seizures › Surgical treatment needed
then taper over 4 weeks* › MDR TB meningitis
• Surgical therapy, if indicated
› Slower taper needed in some patients › No improvement/deterioration after
› External ventricular drain
Equivalent dose of another steroid formulation
* 2-4 weeks of treatment
may be used either injectable/oral › VP shunt
• Need for ICU care
ABBREVIATIONS
AFB: Acid-fast Bacillus CXR: Chest X-ray MDR: Multi-drug Resistant TB: Tuberculosis
CBC: Complete Blood Count HIV: Human Immunodeficiency Virus MGIT: Mycobacteria Growth Indicator Tube TBM: Tubercular Meningitis
CECT: Contrast Enhanced Computed Tomography HRZE: Isoniazid; Rifampicin; Pyrazinamide; Ethambutol MRI: Magnetic Resonance Imaging TLC: Total Leucocyte Count
CSF: Cerebro-spinal Fluid ICU: Intensive Care Unit NAAT: Nucleic Acid Amplification Test VP: Ventriculo-peritoneal
CT: Computed Tomography LP: Lumbar Puncture NTEP: National TB Elimination Programme WBC: White Blood Cells

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 05 March, 2022.
2. Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family
Welfare, Government of India https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 05 March, 2022.
This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
Adul t Extrapulm onar y
Tuberculosis
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


ADULT ABDOMINAL TUBERCULOSIS
ICD-10-A18.3
WHEN TO SUSPECT
Any organ in abdominal cavity, including gut lumen & peritoneum may be affected

PERITONEAL INTESTINAL ESOPHAGEAL GASTRO-DUODENAL PERIANAL PANCREATIC HEPATO-BILIARY


• Recurrent intestinal • Dysphagia • Gastric outlet • Simple/ • Abdominal pain • FUO
• Abdominal
colic • Odynophagia obstruction Complex • Obstructive
distension • Hepatomegaly
• Partial/ incomplete peri-anal fistula jaundice
• Hematemesis • Gastrointestinal • Jaundice
• Pain abdomen intestinal obstruction • Persistent • Dilated
• Constitutional bleed
• Chronic diarrhoea discharge pancreatic or • Elevated ALP
• Fever symptoms
• Weight loss • Fistulae which bile duct with • SOL
• Palpable mass recur after (peri)-pancreatic • Hepatic abscess
abdomen multiple mass or cyst
• Lower surgeries • Constitutional
gastrointestinal symptoms
bleeding

EVALUATION FOR SUSPECTED ABDOMINAL TUBERCULOSIS


Pancreatic
Peritoneal TB Gastrointestinal TB Perianal TB
Hepatobiliary TB

Ascitic tap • Imaging:


• Cytology (lymphocyte › CT or MR enterography (preferred): bowel • Uncommon • Malignancy more
predominance, absence thickening, strictures, necrotic LN important concern
• Imaging: MRI
of malignant cells) › CT chest may also be done • Needs imaging/
pelvis/Endoanal
• SAAG: <1.1 gram/dL • Endoscopic biopsies: UGIE for Endoscopic
ultrasound/EUS
• Culture, NAAT esophageal/gastroduodenal/ileo-colonoscopy ultrasound guided
for intestinal TB is mandatory to acquire tissue • Tissue acquisition tissue acquisition
• Ascitic ADA: >39 U/L •
• Histology: Caseating granuloma specific; for histology & • Refer to higher
Imaging
microbiology centre
• Ultrasound: Ascites, confluent granuloma & ulcers lined by
lymph nodes, bowel histiocytes suggestive
thickening, for tissue • Microbiology: Culture, NAAT
acquisition for cytology & • Barium studies: if endoscopy/CT unavailable
microbiology

If diagnosis unclear If diagnosis unclear


Refer for Laparoscopy Refer for further evaluation (differentiating Crohn’s disease is challenging)
Trial of Anti tubercular therapy with careful follow-up

HIV & blood sugar test should be done in all suspected patients as per NTEP
guidelines

FOLLOW UP
Definitive Abdominal TB Clinically Diagnosed Abdominal TB
(Microbiological positive, Caseating (Consistent clinical/radiological picture, TREATMENT:
granulomas) Elevated ascitic ADA, granuloma on his- • Start treatment & follow-up as
tology, exclusion of differential diagnosis) per NTEP guidelines
• 1st line treatment for adults &
START ATT (2HRZE, 4HRE) children with abdominal TB:
2HRZE/4HRE
Clinical Assessment

(4 & 8 weeks)
• No fever/pain, disappearance of abdominal distension, weight gain • Extend duration of treatment in
• Assess ATT induced hepatotoxicity with serial LFTs cases of inadequate response
• Refer for surgical management
Improvement +

Assessment for clinically diagnosed cases for complications [intestinal


No pro eek

• Peritoneal TB: Ultrasound for ascites (4-8 weeks)


Im 8 w

obstruction (due to strictures),


at

• Intestinal TB: Ileo-colonoscopy (8-12 weeks) perforation]. Consider


ve s

endoscopic dilatation for


m

nt treatment for accessible


en

No oveme Improvement +
t

Imp
r strictures
• Refer for biliary drainage in case
Refer Refer of Jaundice due to biliary
Complete ATT (Exclude alternative diagnosis) Complete ATT
(Exclude MDR) obstruction (hepatobiliary
obstruction/pancreatic TB)
• End of therapy: Document mucosal healing in colonic & upper GI TB
• Imaging in small bowel disease to document healing

ABBREVIATIONS
ADA: Adenosine Deaminase FUO: Fever of Unknown Origin MR: Magnetic Resonance Rif: Rifampicin
ALP: Alkaline phosphatase GI: Gastro-intestinal Mtb: Mycobacterium Tuberculosis SOL: Space occupying Lesion
ATT: Anti-Tubercular treatment HRZE: Isoniazid; Rifampicin; NAAT: Nucleic Acid Amplification Test SAAG: Serum Ascites Albumin Gradient
CT: Computed Tomography Pyrazinamide; Ethambutol NTEP: National TB Elimination UGIE: Upper gastrointestinal endoscopy
LFT: Liver function tests
EUS: Endoscopic ultrasound Programme
MDR: Multi-drug resistance
REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India. https://tb-
cindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 08 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare,
Government of India accessed at https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 08 March, 2022.
This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


ADULT LYMPH NODE TUBERCULOSIS
ICD-10-A18.2
WHEN TO SUSPECT?
WHEN TO • Swelling (>1 cm) in neck, armpit or groin (>2 cm) +/- redness, fluctuation, sinus
discharge
SUSPECT? • May or may not be associated with fever, weight loss, night sweats or cough
• History of similar swelling in the past / past history of tuberculosis
• History of contact with a patient with a diagnosis of TB

DIAGNOSTIC ALGORITHM
Lymphnode enlargement > 1cm ± systemic symptoms*

ABDOMINAL/MEDIASTINAL (INACCESSIBLE)

FNAC / LN aspirate Sputum / induced sputum

Send for NAAT# Send for NAAT#

+ve -ve +ve -ve

Treat as LN TB LN biopsy (refer if indicated) Treat as LN TB Refer for FNAB

LN tissue for Tissue for


• NAAT
*
Tender LN, fluctuation, pain, fever, weight loss, night sweats • NAAT
#
Xpert/TrueNat/ ICMR or CTD approved test • Cultures/ LPA
• Cultures$/ LPA $
MGIT/LJ

Treatment : As per NTEP Guidelines

ASSESS RESPONSE TO THERAPY AT 3-4 MONTHS


Response to therapy at 3 months
• Resolution: Decrease in size of LN with
settling of systemic symptoms
Yes No
• Delayed response -Paradoxical reaction:
Increase in size of LN or new signs of
inflammation (up to 3 months of starting Symptom resolution
Increase in size of LN ± Constitutional
treatment) OR appearance of new LN at symptoms persist
signs of inflammation
same/other site Continue ATT
• May require tissue cultures, if not done, to Check old culture report
Send new cultures if not R/o alternate
rule out treatment failure/resistance
available diagnosis
• Therapeutic drug monitoring to ensure
adequate drug levels Susceptible TB Drug resistant TB
• If cultures reveal susceptible TB it is likely
due to paradoxical worsening: May require
anti-inflammatory agents (inaccessible)/ Paradoxical Therapeutic drug Refer to DOTS
worsening monitoring plus centre
surgical removal (accessible)
Refer to higher centre •

COMPLICATIONS BCG LYMPHADENITIS


• Abscess formation • Age is usually < 2 years
• Rupture may lead to sinus formation • Axillary and/or supraclavicular LN on same side as BCG
vaccination (usually given on left)
REFER TO HIGHER CENTRE IF • No systemic symptoms in immunocompetent children
• Non responders • Treatment:
• Needs treatment for Drug Resistance • Wait & watch if small
• Large Nodal Mass/Abscess requiring • If large & suppurative, repeated aspiration or rarely
surgical intervention incision & drainage is required
NAAT/AFB smear positivity can not differentiate between BCG & MTB

ABBREVIATION
ATT: Anti Tubercular Treatment FNAB: Fine Needle Aspiration Biopsy LPA: Line Probe Assay NTEP: National TB Elimination
BCG: Bacille Calmette Guerin FNAC: Fine Needle Aspiration MGIT: Mycobacterial Growth Indicator Programme
CTD: Central TB Division Cytology Tube PCR: Polymerase Chain Reaction
DOT: Directly Observed Treatment LJ: Lowenstein Jensen MTB: Mycobacterium Tuberculosis
TB: Tuberculosis
Short-course LN: Lymph Node NAAT: Nucleic Acid Amplification Test

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India.
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last accessed on 11 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare, Government of India.
https://tbcindia.gov.in/showfile.php?lid=3590 Last accessed on 11 March, 2022.
3. Gaikwad P, Samuel VM, Rupali P. Tb or not Tb. Paradoxical response and the role of selective lymphadenectomy in tuberculous cervical lymphadenitis. Indian J of Applied Research, October 2016; Vol 6(10): 40-43.
4. Alsultan A, Peloquin CA. Therapeutic drug monitoring in the treatment of tuberculosis: an update. Drugs, 2014 Jun; 74(8):839-54. Erratum in: Drugs. 2014 Jun; 74(9):2061.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


ADULT MUSCULOSKELETAL TUBERCULOSIS
ICD-10-A18.0
SPINE TUBERCULOSIS OTHER JOINTS/BONES
• Persistent localized pain in spine region • Persistent localized pain & swelling >6
>6 weeks, night pains weeks
• Local tenderness/cold abscess • Mono-articular joint involvement
WHEN TO • Recent onset deformity in the back • Discharging sinus (+/-)
• Recent neurological deficit (better to
SUSPECT? refer*)
• Fluctuant swelling with or without
inflammation
• Persistent heaviness around the • Painful restriction of involved joint
waist/Girdle pain movements
• Fever, cough, weight loss & night pains • Wasting around the area
• History of close contact with TB • Fever, cough, weight loss & night pains
• History of close contact with TB

DIAGNOSTIC ALGORITHM
Presumptive TB

ESR, CRP, LFT, Imaging : X-rays spine &


KFT, HIV chest, (MRI, if feasible)

Features s/o TB
Paravertebral Obliterated disc T1WI and T2WI images T2WI septate
shadow space & bone loss bone edema with VB pre/para
in X-rays destruction vertebral abscess
in MRI

Findings S/o TB
In case of psoas abscess or Biopsy facilities not
soft tissue abscess: USG available: Refer • X-ray findings(spine):
guided biopsy, bone/joint Lesion not accessible › Regional Osteopenia
biopsy (open or percutaneous) for biopsy : Refer* › Decreased/obliterated disc space
› Vertebral erosions +/- reduced vertebral height
› Paravertebral shadow
Send samples for: Gram staining & Culture
• MRI findings (Spine):
sensitivity, AFB staining, HPE, NAAT, Solid &
liquid mycobacterium culture, LPA if feasible › Contagious VB involvement with relatively preserved disc
› Pre & paravertebral septate collection (Abscess)
› Epidural encroachment +/- intraosseous abscess
MTB +ve MTB -ve • X-ray & MRI Finding (extraspinal):
› Regional osteoporosis with bone destruction on X-rays
Start ATT Refer to higher centre › Inflammation of bone(T1WI & T2WI) +/- abscess on MRI

TREATMENT
Treatment should be started & follow-up should be conducted as per NTEP guidelines
The following algorithm provides additional guidance for follow-up

TB +ve on any test TB -ve on all tests

NAAT sensitive to GeneXpert resistant to Index of suspicion Index of suspicion


Rifampicin: Start 4 drug Rifampicin: refer*/culture for TB high ESR, CRP raised: low CRP normal:
first line ATT and sensitivity to other drugs Refer* Reassurance

• Clinical symptoms improvement


• CRP decreasing continue for standard 12 months regime
• Intensive 4 drug regime (not more than 4 months)
• Stop ATT after 12 months if all three parameters clinical, Lab(ESR, CRP) &
radiological return to normal
• In case of spine decision to stop ATT to be taken by evaluating healed status on Clinical symptoms not improving
contrast MRI
ESR, CRP increasing: Refer*
• Mildly elevated ESR, CRP (non specific tests) can be ignored
• Follow up every month with CRP, LFT during intensive phase ?Suspected drug resistance
• Follow up every 3 months during continuation phase with CRP/LFT
• On treatment worsening of symptoms
› Early (<3 months): Paradoxical
› Late (>4 months): ?drug resistance
• Any aberrance in course such as appearnce of nerual deficit: Refer*

Refer to higher centre where advanced diagnostic, & therapeutic facilities including surgical procedures are
*

available.

ABBREVIATIONS
AFB: Acid-fast Bacillus HIV: Human Immunodeficiency Virus MRI: Magnetic Resonance Imaging
HPE: Histopathological examination NTEP: National TB Elimination Programme
ATT: Anti-Tubercular Treatment TB: Tuberculosis
KFT: Kidney Function Tests USG: Ultrason bography
CRP: C-Reactive Protein
LFT: Liver Function Tests VB: Vertebral body
ESR: Erythrocyte Sedimentation Rate LPA: Line Probe Assay WNL: Within Normal Limits

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last accessed on 10 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare,
Government of India https://tbcindia.gov.in/showfile.php?lid=3590 Last accessed on 10 March, 2022.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


ADULT PERICARDIAL TUBERCULOSIS
ICD-10-A18.84

WHEN TO SUSPECT COMPLICATIONS


SYMPTOMS Constrictive pericarditis: Clinical Cardiac tamponade: Clinical
signs include
• Cough, fever, breathlessness or signs for recognition include • Sinus tachycardia
pleuritic chest pain • Kussmaul's sign (lack of an • Hypotension with a narrow pulse
inspiratory decline in jugular venous pressure
• May be associated with weight loss,
pressure) • Elevated JVP jugular venous
night sweats or difficulty lying pressure
down • Elevated & distended jugular veins
• Muffled heart sounds
with a prominent Y descent (second
• Past history or a history of contact • Pulsus paradoxus (a decrease in
inward deflection of internal jugular systolic blood pressure by >10
with a patient with a diagnosis of
pulse due to diastolic inflow of blood mmHg on inspiration)
tuberculosis
into the right ventricle) • Ascites
• Examination reveals tachycardia,
• Pericardial knock (rare)
increased jugular venous pressure, Other complications:
hepatomegaly, ascites, & peripheral • Myopericarditis: Abnormal ejection
edema fraction with evidence of myocarditis
• A pericardial friction rub and INVESTIGATION and pericarditis (elevated cardiac
Essential tests: enzymes & ST elevation on ECG)
distant heart sounds present on
• Chest X-ray
cardiovascular examination Desirable: • Effusive constrictive pericarditis:
• ECG
• Cardiac enzymes Mixed clinical picture. Main clue is
• If clinical picture +/- heart US • Echocardiogram
• CT/MRI of Thorax elevated JVP clinically & right atrial
suggest pericarditis or pericardial
• Pericardiocentesis pressure on ECHO in spite of removal
effusion refer for echo-cardiogram • Pericardial biopsy
of pericardial fluid

DIAGNOSIS
SUSPICION OF PERICARDIAL TUBERCULOSIS

CXR & ECG

Cardiomegaly or Pericardial CXR normal, ECG: ST elevation CXR & ECG Normal
calcification

ECHO ± CT thorax
Look for alternate diagnosis

Pericardial effusion Constrictive physiology +


pericardial thickness >4 mm

ATT + steroids
Pericardiocentesis
Yes Stop steroids but
Response at 11 weeks
Exudate with pleocytosis continue ATT
Pericardial fluid
but TB NAAT –ve No
- TC, DC, LDH, sugar, protein
OR ADA <40 U/L
- ADA, TB NAAT Refer for pericardiectomy
- AFB C/s
HIV
Pericardial tissue for TB NAAT,
+ve - ve Exudate + TB NAAT +ve AFB C/s, Histopathology
OR Exudate ± ADA ≥ 40 U/L
Look for features R/o viral
pericarditis
of lymphoma Granulomas ± caseation
- ve Likely Pericardial TB TB NAAT +/-
+ve
Symptomatic Therapeutic
treatment trial of ATT Start ATT Continue ATT and check response

MANAGEMENT
TREATMENT NON RESPONSE TO STEROIDS & ATT
• Antitubercular therapy is advised as per NTEP
• Should prompt a referral to a specialist center for
• Steroids are recommended in large pericardial
confirmation of diagnosis
effusions, prominent pleocytosis & pericardial fluid
with high inflammatory markers or early • Should prompt an evaluation for alternative causes of
constriction effusio-constrictive pericarditis: viral infections,
• Give Prednisolone 60 mg/day for 4 weeks, 30 systemic lupus erythematosus, primary effusion
mg/day for 4 weeks, 15 mg/day for 2 weeks & lymphomas or pericardial malignancies
5 mg/day for 1 week • Non response of cardiac symptoms to anti-tuberculous
• Total duration of systemic steroids is 11 weeks therapy cardiac surgical evaluation may be required

ABBREVIATION
ADA: Adenosine Deaminase CXR: Chest X-ray JVP: Jugular Venous Pressure
ATT: Antituberculous Therapy ECG: Electrocardiogram NTEP: National Tuberculosis Elimination Programme
ECHO: Echocardiogram TB: Tuberculosis

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India accessed at
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 15 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare,
Government of India https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 15 March, 2022.
3. Nahid P, Dorman SE, Alipanah N, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America Clinical Practice Guidelines: Treatment
of Drug-Susceptible Tuberculosis. Clin Infect Dis. 2016 Oct 1;63(7):e147-e195. doi: 10.1093/cid/ciw376. Epub 2016 Aug 10.
This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


ADULT PLEURAL TUBERCULOSIS
ICD-10-A15.6

INVESTIGATIONS
ESSENTIAL DESIRABLE
HISTORY • CXR (to confirm pleural • CT chest (before
• Fever effusion) pleural biopsy)
• Pleuritic chest pain • Sputum for AFB/NAAT • Pleural biopsy
WHEN TO • Cough
• Breathlessness
• Refer immediately for pleural
tap
(image-guided/thorac
oscopic) (If diagnosis
SUSPECT? • Anorexia • Thoracentesis is uncertain)
• Weight loss (ultrasound-assisted) • Histopathology
• History of TB contact • Pleural fluid analysis : • MGIT
› Cell count (total and differential)
› Protein
EXAMINATION › Glucose
• Dullness to percussion › Gram stain
• Decreased/absent › Bacterial cultures
breath sound › Stain for acid-fast bacilli
› Adenosine deaminase (ADA)
› NAAT
› Cytology evaluation

DIAGNOSTIC
Pleural effusion

Alternate etiology:
Sputum examination and transudative, exudative
thoracentesis (bacterial, malignancy)

Yes Sputum or pleural fluid


Start anti-TB treatment Treat accordingly
positive for AFB or NAAT

No

Pleural fluid ADA

< 40 U/L ≥70 U/L


40-69 U/L

No
Pleural biopsy Age <40 years, fever, non-smoker,
alternate etiology unlikely
Initiate empiric anti-TB
Yes therapy
Treat based on results of Initiate empiric anti-TB therapy
biopsy and microbiological
examination
If no response in 4 weeks

MANAGEMENT

TREATMENT AND RESPONSE FOLLOW UP


• Most patients who respond to treatment will have
• As per NTEP
improvement in their general condition by 2
• Therapeutic pleural tap can be done under weeks, and significant improvement in pleural
ultrasound assistance if the effusion is large, and effusion by 4-8 weeks
the patient is breathless
• Disappearance of constitutional symptoms with
decrease in pleural effusion suggests
WHEN TO REFER? responsiveness to treatment
• Facility for ultrasound assistance is not available • Increase in pleural effusion can suggest
• Diagnosis is not established after thoracentesis and › Paradoxical reaction or
facilities for pleural biopsy is not available › Drug-resistant TB or
• Drug-resistant TB is detected: according to NTEP › Alternative etiology
• Worsening pleural effusion on follow up • A follow up CXR at 4-8 weeks after starting ATT is
useful to assess progress

ABBREVIATIONS
ADA: Adenosine Deaminase CT: Computed Tomography NAAT: Nucleic Acid Amplification Test
AFB: Acid-fast Bacilli CXR: Chest Radiograph NTEP: National Tuberculosis Elimination Programme
ATT: Anti Tubercular Treatment MGIT: Mycobacterial Growth Indicator Tube TB: Tuberculosis

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 11 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare,
Government of India. https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 11 March, 2022.
3. Sharma SK, Ryan H, Khaparde S, et al. Index-TB guidelines: Guidelines on extrapulmonary tuberculosis for India. Indian J Med Res. 2017;145(4):448-463. doi:10.4103/ijmr.IJMR_1950_16
4. Lo Cascio CM, Kaul V, Dhooria S, Agrawal A, Chaddha U. Diagnosis of tuberculous pleural effusions: A review. Respir Med. 2021;188:106607. doi:10.1016/j.rmed.2021.106607.
5. Light RW. Update on tuberculous pleural effusion. Respirology. 2010 Apr;15(3):451-8. doi: 10.1111/j.1440-1843.2010.01723.x.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


ADULT TUBERCULAR MENINGITIS
ICD-10-17.0
SUSPECT TBM WITH ALWAYS ENQUIRE FOR
FOLLOWING CLINICAL FEATURES ASSOCIATED FEATURES
• Fever (Duration of 5 days or more#†) • Constitutional symptoms
• Headache & Vomiting • Active TB elsewhere
• Altered sensorium • Past history of TB & ATT
• Cranial nerve palsy • Contact with TB patient
• Hemiparesis/any limb weakness • HIV seropositivity
• Seizures • Low socio-economic status
• Neck pain and stiff ness • High endemic area
#
This is to increase sensitivity for diagnosis of TBM. The duration could be variable from days to weeks to months.

Clinical judgement & evaluation of other conditions is also required as fever can be associated with headache in
other medical conditions. Delaying work up for meningitis is not recommended.

IF TBM SUSPECTED
Refer to a centre where facility of evaluation (at least Lumbar puncture & CT scan) is available.

EVALUATION AT CENTRE OF CARE


CLINICAL HISTORY & EXAMINATION COMMON NEUROIMAGING FINDINGS IN TBM
• Symptoms type & duration, onset &
progression
• Headache, altered sensorium, focal
deficits
• Neck rigidity, Kernig’s sign
• Cranial nerve palsy
• Fundus examination - papilledema
Basal exudates and Hydrocephalus Tuberculomas Infarction
LABORATORY EVALUATION Arachnoiditis Pott’s spine
• CBC, ESR, CRP
• LFT, RFT, Electrolytes CSF EVALUATION*
• Blood sugar, HIV
• Chest X Ray- PA view
01 02 03
• USG whole abdomen
• Mantoux (optional) OPTIONAL
ESSENTIAL DESIRABLE
IMAGING • Cell count & type
• Fungal smear & culture • Wet mount
• NCCT/CECT head- Preferred as • Protein
• Cytopathology# • VDRL
initial investigation • Sugar (& Correspon-
• Toxoplasma PCR†
ding blood sugar)
• MRI brain (and spine if • Viral PCR
• NAAT
indicated) in selective cases • Grams stain
• Bacterial culture If some tests are not available at site,
CSF • AFB stain store sample in sterile container, keep in
• Mandatory- Should be sent for • AFB culture/sensitivity refrigerator & transport in icebox to other
essential analysis (Box 1) • India Ink** facility
• Prudent to perform CT head prior to • Cryptococcal antigen**
CSF in presence of papilledema & /or *
CSF samples should be sent to the lab as soon as possible for examination of cells, protein, sugar and cytology.
focal deficits Cryptococcal meningitis should be excluded wherever possible as it is a close differential diagnosis of TBM.
**

#
In ideal settings, it may be prudent to exclude a diagnosis of carcinomatous meningitis.

Especially in patients with HIV.

CSF FINDINGS IN TBM AND OTHER MENINGITIS


MENINGITIS CELL COUNT PREDOMINANT CELL TYPE PROTEIN SUGAR SPECIFIC TESTS FOR
TYPE CONFIRMATION
Tubercular Usually <500 Lymphocytic High Low AFB smear & culture
Neutrophilic in some acute cases NAAT*ф
Pyogenic In thousands Neutrophilic Moderately High Very low Gram stain, culture
Fungal Variable Lymphocytic High Low India Ink, Fungal Culture,
Cryptococcal antigen
Viral 50-500 Lymphocytic Normal to Normal PCR for specific virus
marginally high
*
A negative NAAT result does not rule out TBM. The decision to give ATT should be based on clinical features and CSF profile.
ф
NAAT: Xpert/TrueNat
MANAGEMENT FOLLOW UP SUSPECT COMMON COMPLICATIONS
ANTI-TUBERCULAR TREATMENT • Regular follow up is Hydrocephalus and raised ICP: Worsening of headache with
• Intensive Phase: 2 months of RHZE or RHZS essential every month for at vomitings and/or altered sensorium
• Continuation phase: 3 drugs: RHZ# for at least 10 least first 3 months & can be Optico-chiasmatic arachnoiditis: Complaints of vision loss in one or
months* increased thereafter till both eyes with or without headache
STEROIDS treatment is stopped Myelitis and or arachnoiditis: Development of paraparesis or
• Preferably Dexamethasone 0.4 mg/kg/day • Monitor liver function tests quadriparesis with/without sensory disturbances, bladder
intravenously in 3-4 divided doses during hospital & any other features of drug involvement
stay toxicity Epidural abscess/Pottʼs spine: Complaints of back pain and/or
• If not feasible, give oral Dexamethasone weakness in one/ both lower limbs/ bladder/ bowel disturbances
0.4 mg/kg/day in divided doses or oral Prednisolone • Observe for clinical Tuberculoma: Seizures, new onset focal focal deficits, worsening
1 mg/kg/day in single morning dose improvement or any
headache
• Discharge on oral steroids on tapering doses for a deterioration
Seizures: Consider tuberculoma/electrolyte or metabolic
total duration of 8-12 weeks • Closely observe for imbalance/ cerebral infarction
*
treatment duration may be increased in some cases as per the development of any Cerebral infarction and stroke: Sudden onset weakness of one half
clinician decision
#
This is as per strong recommendations of concerned specialty complications of body, new onset confusion, altered mental status, seizures
experts in view of high toxicity of Ethambutol on TBM. These
recommendations have been sent to NTEP Hyponatremia, SIADH: Persistent or worsening mental status

ABBREVIATIONS
ATT: Antitubercular therapy E: Ethambutol MRI: Magnetic resonance imaging R: Rfimapicin
CBC: Complete Blood Count ESR: erythrocyte sedimentation rate NAAT: Nucleic Acid Amplification Test RFT: Renal function tests
H: Isoniazid NCCT: Non-contrast CT S: Streptomycin
CECT: Contrast Enhanced CT SIADH: Syndrome of inappropriate antidiuretic hormone
CRP: C Reactive Protein ICP: Intracranial pressure NTEP: National TB Elimination Programme TBM: Tubercular meningitis
CSF: Cerebrospinal Fluid LFT: Liver function tests PCR: Polymerase Chain Reaction Z: Pyrazinamide
REFERENCES
1. Thwaites G, Fisher M, Hemingway C, Scott G, Solomon T, Innes J; British Infection Society. British Infection Society guidelines for the diagnosis and treatment of tuberculosis of the central nervous system in adults and children. J Infect. 2009;59:167-87.
2. Thwaites GE, Chau TT, Stepniewska K, Phu NH, Chuong LV, Sinh DX, White NJ, Parry CM, Farrar JJ. Diagnosis of adult tuberculous meningitis by use of clinical and laboratory features. Lancet. 2002;360:1287-92.
3. Vibha D, Bhatia R, Prasad K, Srivastava MV, Tripathi M, Kumar G, Singh MB. Validation of diagnostic algorithm to differentiate between tuberculous meningitis and acute bacterial meningitis. Clin Neurol Neurosurg. 2012;114:639-44.
4. Modi M, Prabhakar S. Fever and altered sensorium. In Singh MB, Bhatia R eds. Emergencies in Neurology. 2nd edition. 2021. 91-106.
5. INDEX-TB guidelines. https://tbcindia.gov.in/showfile.php?lid=3245 Last access on 05/03/2022.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


CUTANEOUS TUBERCULOSIS
ICD-A18.4
WHEN TO SUSPECT TYPES OF CLINICAL DISEASE
• Presence of ulcer or discharging • Primary Inoculation tuberculosis
sinus over lymph node, bone & • Tuberculosis verrucosa cutis
joints
• Lupus vulgaris
• Persistent asymptomatic reddish/
reddish brown lesion of >6 months • Scrofuloderma
duration which may show scarring • Acute miliary tuberculosis
ETIOLOGY • Persistent warty or verrucous • Orificial tuberculosis
lesion of >6 months duration • Metastatic tuberculous
• M.tuberculosis • Abscess (tuberculousgumma)
• M.bovis • Normal primary complex–like reaction
• NTM OTHER FEATURES
• Postvaccination
• BCG (rarely) • Extracutaneous involvement
• Perforating regional adenitis
• Lymph node & lungs involvement
• Lichen scrofulosorum
• Other organ systems involvement
(bones, GIT & CNS) • Papulonecrotictuberculid
• Facultative tuberculids
• Nodular vasculitis & Erythema nodosum

Lupus Vulgaris Lupus Vulgaris Scrofuloderma Scrofuloderma Verrucous TB Verrucous TB

INVESTIGATION
INVESTIGATIONS SCREENING FOR SYSTEMIC INVOLVEMENT CASE DEFINITION
• Histopathology: Granulomas • Examination: A) Confirmed case:
with epithelioid histiocytes & › Lymph node to be examined (FNAC) › M.tuberculosis complex
Langerhans - type giant cells › Other organ system can be done if identified by either culture or
indicated NAAT or histology shows typical
• FNAC: If indicated
• Essential: morphology
• IGRA/PCR: Not › Full course of ATT which led to
› Chest X-ray
recommended for diagnosis complete clearance of lesions
› FNAC from the indurated part of lesion
• Desirable: B) Probable case:
› Histopathology › Typical skin lesion with no
positive features/investigation as
› Culture from biopsy sample (Not swab)
mentioned above (A)

DIAGNOSTIC ALGORITHM
Suspected TB case based on presence of clinical signs
• Ulcers/discharging sinuses over sites of LN, bones & joints
• Persistent, asymptomatic raised reddish/reddish brown lesion of >6 months’ which may show scarring at one end
• Persistent, warty skin lesion of >6 months’

Skin biopsy* for histopathology ± culture + CXR • Strong clinical suspicion


› Start ATT
Refer to dermatologist with expertise in cutaneous TB
*FNAC can be done if facilities for
Histology diagnostic Histology equivocal Histology negative & skin biopsy are not available
and/or culture +ve and culture -ve culture -ve

Mantoux Test
Treat for cutaneous TB Do not Treat

Positive (often strong) Negative

MANAGEMENT
TREATMENT FOLLOW UP
• Similar to Pulmonary TB as per NTEP • 1st follow-up after 4-6 weeks; majority improves
• DR -TB to be kept in mind • If no response after 8 weeks
• No role of steroids, oral or topical, in • Alternate diagnosis/DR-TB; refer to higher centre
management of CT

ABBREVIATION
ATT: Anti-Tubercular treatment DR-TB: Drug resistant Tuberculosis NAAT: Nucleic acid amplification test
BCG: Bacille Calmette Guerin vaccine FNAC: Fine needle aspiration cytology NTEP: National TB Elimination Programme
CNS: Central Nervous system GIT: Gastro-intestinal tract NTM: Non-Tuberculous Mycobacterium
CT: Cutaneous Tuberculosis IGRA: Interferon Gamma Release assay PCR: Polymerase chain reaction test
CXR: Chest X-ray LN: Lymph node TB: Tuberculosis

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 15 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 15 March, 2022.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


FEMALE GENITAL TUBERCULOSIS
ICD-10-A18.17
SUSPECT
Consider following symptoms Clinical Examination
in history : • General Physical Examination
• H/O infertility (primary or • Pelvic Examination (cervical growth, uterine
secondary) size and mobility, adnexal tenderness & mass)
• Chronic lower abdominal or
Abdominal and Pelvic USG (TVS)
pelvic pain
• Uterus, adnexa & pelvis to be evaluated
• Amenorrhoea or other preferably by transvaginal scan
WHEN TO menstrual disturbances • Endometrial cavity & vascularity to be
SUSPECT? • Abnormal vaginal discharge looked carefully with colour Doppler
• Constitutional symptoms of Specific Investigations
TB (low grade fever, weight • Endometrial sampling or biopsy with Pipelle
loss etc.) device or Karman cannula (4 mm) for
• Other symptoms related to microbiological & histopathological
extra-genital TB (abdominal, examination
CNS, bone and lymph nodes • Endoscopy :
etc.) › Hysteroscopy & laparoscopy to evaluate
uterus, adnexa & other pelvic organs along
with lower abdomen
› Laparoscopic biopsy from peritoneum or ab-
dominal/pelvic lesions
In addition, standard • MTB diagnosis from biopsy specimen
investigations for TB to (endometrium & other tissues) by
› Smear microscopy (AFB smear) & culture
be carried out › Gene Xpert or other NAAT
› HPE of biopsy specimen

DIAGNOSIS
SUGGESTIVE FINDINGS IN FGTB FEMALE GENITAL TB (STEPWISE DECISION)
Imaging and Radiological • Clinical history
• HSG : to be avoided in acute phase • General physical and pelvic examination
Findings : blocked fallopian tubes, • Pelvic ultrasound
usually cornual; tobacco pouch • HSP as indicated in infertility HSG
appearance of the tubes; beaded
Definite FGTB needing ATT if any of the following tests are positive
tubes; filling defect in the uterine
• AFB microscopy positive
cavity (Asherman syndrome)
• AFB culture positive
• USG : cogwheel appearance of tubes;
• Gene Xpert or other NAAT +ve
uterine cavity may show thin diffuse
• Histopathological demonstration of epithelioid granuloma
endometrium with irregular borders
Probable FGTB needing ATT if any of following positive
• CT/MRI : can be used for tubo-ovarian
• Clinical findings/suspicion of TB with tubo-ovarian masses on
mass
imaging studies
Endoscopy • Clinical findings/suspicion of TB with laparoscopic findings of
beaded tubes, caseous nodules, tubercles, adhesions, hydrosalpinx &
• Hysteroscopy : To look for tubercles,
pyosalpinx etc.
pale endometrium & endometrial
adhesions • Clinical findings/suspicion of TB with hysteroscopic findings of
tubercles, caseous nodules, pale endometrium, intrauterine
• Laparoscopy : Direct visualization of adhesions etc.
tubercle like lesions on the uterus, Negative FGTB : No ATT
tubes and other pelvic organs
• No microbiological, histological, radiological, laparoscopic &
including peritoneum, & caseous
hysteroscopic evidence of FGTB
nodules
Menstrual blood should not be used for NAAT.

MANAGEMENT
TREATMENT FOLLOW UP
• Treatment of FGTB should be as per NTEP Follow-up of the patient should be flexible depending on
• Patients requiring specific treatment such the clinical presentation and response to ATT
as infertility, Asherman syndrome & • 1 month : Clinical Evaluation (General & Gynaecological)
tubo-ovarian mass etc. should be referred • 3 months : Clinical Evaluation (General & Gynaecological)
to higher centres
• 6 months : Clinical Evaluation & Investigations (endometrial
biopsy, hystero-laparoscopy & USG as needed)

ABBREVIATION
AFB: Acid-Fast Bacilli FGTB: Female Genital TB MRI - Magnetic Resonance Imaging PCR: Polymerase Chain Reaction
ATT: Anti-Tuberculosis Therapy FNAC: Fine-needle Aspiration Cytology MTB: Mycobacterium Tuberculosis TB: Tuberculosis
CNS: Central Nervous System HSE: Histopathology Examination NAAT: Nucleic Acid Amplification Test TVS: Transvaginal Scan
CT: Computed Tomography HSG: Hysterosalpingography NTEP: National Tuberculosis Elimination USG: Ultrasonography
Programme

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India. https://tb-
cindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 08 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare,
Government of India accessed at https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 08 March, 2022.
3. Sharma JB, Sharma E, Sharma S, Dharmendra S. Recent advances in diagnosis and management of female genital tuberculosis. J Obstet Gynaecol India. 2021;71:1-12.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


GENITOURINARY TUBERCULOSIS
ICD-A18.10

WHEN TO SUSPECT? PRESENTING SYMPTOMS

Fever Urinary Tuberculosis Male Genital Tuberculosis


• LUTS (frequency, urgency and (MGTB)
+/-
nocturia) with dysuria and/or • Scrotal pain or swelling for 2 weeks
SYSTEMIC or more
Weight loss haematuria for at least 2 weeks
SYMPTOMS • Not responding to a 7–14 day course
• Not responding to a 3–7 day course of antibiotics, or
Night sweats of antibiotics • Discharging sinuses in the scrotum
• Rarely infertility

INVESTIGATION
*Deranged renal function Refer to higher
Essential centre/Urologist
**HDN/HDUN
• CBC
• KFT*
• LFT
• ESR Specific Investigations
• Chest X ray • If normal renal function
• Urine R/M and Culture › IVP/CT urography
• Urine for AFB x 3-5 days (early
morning, first void) • If deranged Renal Function
• Urine Culture for MTB x 3-5 days › MR Urogram
(early morning, first void) › Retrograde Pyelography
• NAAT assay (GeneXpert MTB/RIF) › Nephrostogram
• USG KUB**
• USG Scrotum (for MGTB only)

Optional ( If other tests are inconclusive


with high suspicion of GUTB)
• FNAC/ Biopsy- from accessible mass lesions
or fluid collections
• Cystoscopic biopsy of Genitourinary tract

TREATMENT

TYPE OF TB TYPE OF REGIMEN DRUGS EXTENSION CRITERIA


Extension packets of infection,
DRUG SUSCEPTIBLE TB DS-TB REGIMEN 2 MONTHS H,R,E,Z concurrent smear positive
4 MONTHS H,R,E cavitary pulmonary disease, CNS
involvement, Delay in positive
cultures converting to negative
Duration can be increased up to
9 to 12 months
MDR/RR OR XDR-TB TREATMENT AS PER NTEP GUIDELINES

FOLLOW UP
At 8 weeks : Resolution of systemic symptoms, improved urinary symptoms, repeat culture if baseline culture positive
After completion of ATT: Repeat culture if baseline culture positive
Repeat imaging: If partial or impending ureteric stricture
Watch for the following complications at each Follow-up visit:
• Severe LUTS suggestive of small capacity bladder
• Deteriorating renal function

ABBREVIATIONS
ATT: Anti-tubercular treatment ESR: Erythrocyte Sedimentation Rate MDR: Multi Drug Resistant RR: Rifampicin Resistant
CT: Computed Tomography H: Isoniazid MTB: Mycobaterium Tuberculosis USG KUB: Ultrasonography Kidney, Ureter and Bladder
CBC: Complete Blood Count HDN: Hydronephrosis MR: Magnetic Resonance URINE AFB: Urine for Acid-fast Bacillus
CXR: Chest X- Ray HDUN: Hydroureteronephrosis NAAT: Nucleic Acid Amplification Test XDR: Extensively Drug Resistant
DJS: Double J Stent IVP: Intravenous Pyelogram NTEP: National Tuberculosis Elimination Programme Z: Pyrazinamide
DS-TB: Drug Susceptible Tuberculosis LFT: Liver Function Test RFT: Renal Function Test
E: Ethambutol LUTS: Lower Urinary Tract Symptoms R: Rifampicin

References
1. National TB Elimination Programme, Central TB Division. Training modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 11 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare,
Government of India. https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 11 March, 2022.
3. Partin, A. W. et al. Edited (2020). Campbell Walsh Wein Urology (12th ed.). Elsevier.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


INTRAOCULAR TUBERCULOSIS
ICD-10-A18.3
When to suspect Refer to Ophthalmologist for
detailed examination
Ocular Symptoms Eye Care facility should have:
• Blurred vision Mandatory: Slit lamp, ophthalmoscope
• Redness (direct or indirect), intraocular
pressure assessment device
• Photophobia
• Pain in the eye Preferred: Fundus camera, Fundus
fluorescein angiongram(FFA), Optical
• Floaters Coherence Tomography (OCT)
• Flashes of lights

Granulomatous anterior uveitis Examination of the eyes


Clinical signs
• Assess visual acuity
• Anterior chamber cells, Keratic precipitates, Synechiae,
Irregular pupil, RAPD
• Complicated cataract, high or very low intraocular pressure
• Vitritis, Pars plana exudates, Retinal vasculitis, Retinitis,
Choroiditis, Optic nerve head swelling
Intermeditate uveitis Panuveitis/Posterior uveitis Retinal vasculitis Choroiditis

INVESTIGATIONS
Essential: Desirable: Optional: Imaging of eye: Ascertaining diagnosis,
CXR for healed/ Mantoux Test CT Chest (if extent of disease & follow up,
active (standardised available) for teleconsultation
pulmonary TB tuberculin healed/active
units): l0 mm pulmonary TB
induration Retinal Optical Fluorescein
considered positive photographs coherence angiograms
using fundus tomography (if available)
camera scans (if
Investigations to rule out other causes of
available)
clinical presentation

MANAGEMENT
TREATMENT REFERRAL TO HIGHER CENTRE
• ATT : 2 months of RHEZ + 7 months of RH depending • Not confident to treat
on clinical response & side effects to treatment • Vision threatening
• Add pyridoxine 10 mg/day • Non-response to treatment
• Corticosteroids : Topical steroids eye drops for • Side effects due to treatment
severe/anterior chamber inflammation • Atypical reaction
• For treatment in children refer to paediatrician
• Systemic corticosteroids for severe inflammation in
consultation with Uveitis expert

MONITORING AND FOLLOW UP


• Frequency of follow up: 1-2 weeks in 1st month followed by monthly for 3 months & then 3 monthly
• Eye: Clinical grading of inflammation using fundus photographs & OCT scans (if available)
• Steroids:
› Topical: Monitor IOP, cataract and any signs of bacterial/ fungal infection
› Systemic steroids: Monitor body weight, blood sugar & blood pressure

ABBREVIATIONS
ATT: Antitubercular treatment IOP: Intraocular pressure OCT: Optical coherence tomography
E: Ethambutol R: Rifampicin Z: Pyrazinamide
H: Isoniazid RAPD: Relative Afferent Pupilary Defect

REFERENCES
1. Agrawal R, et al.; Collaborative Ocular Tuberculosis Study Consensus Group. Collaborative Ocular Tuberculosis Study Consensus Guidelines on the Management of Tubercular Uveitis-Report 1:
Guidelines for Initiating Antitubercular Therapy in Tubercular Choroiditis. Ophthalmology. 2021 Feb;128(2):266-276. doi: 10.1016/j.ophtha.2020.01.008. Epub 2020 Jan 11. PMID: 32115264.
2. Agrawal R, et al.; llaborative Ocular Tuberculosis Study Consensus Group. Collaborative Ocular Tuberculosis Study Consensus Guidelines on the Management of Tubercular Uveitis-Report 2:
Guidelines for Initiating Antitubercular Therapy in Anterior Uveitis, Intermediate Uveitis, Panuveitis, and Retinal Vasculitis. Ophthalmology. 2021 Feb;128(2):277-287. doi:
10.1016/j.ophtha.2020.06.052. Epub 2020 Jun 27. PMID: 32603726.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
Investigations
&
Treatment
March/2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) of


MICROBIOLOGICAL WORK-UP FOR ADULT EXTRAPULMONARY TUBERCULOSIS

LOGISTICS INVOLVED IN SAMPLE COLLECTION AND TRANSPORTATION REJECTION OF SAMPLES


• Collect Samples for Microbiological work-up in sterile containers before • Unlabelled samples (All specimens
treatment is started. (Mention date & time of collection) MUST be labelled & have a unique
• Specimens to be sent in sterile saline (NOT in formalin) patient identifier)
• Establish linkages between peripheral centres, District centres and • Have no collection date indicated
Tertiary centre/medical colleges/ IRL. Specify details of person to be
• Insufficient quantity - No specimen in
contacted, department and contact number during referrals
container
• Transportation at 2-8 0C
• Damaged - Specimen leaked or
• Maximum time for transportation in cold chain should be 5 days from
broken in transit
time of collection
• Quantity of sample mentioned is only for microbiological work-up. Tests • Samples greater than 3 days old at
like histopathology, cytology, ADA, glucose, protein, etc will require room temperature and more than 5
additional sample days in refrigeration are unreliable
• Microbiological tests for TB (smear, molecular tests, culture) will be specimens for testing
performed as per availability and preparedness of site
• PHC and CHC should perform smear microscopy and molecular Precious samples should be
diagnostic tests. If sample less than 500 µl, refer directly to Tertiary transported to IRL.
centre/medical colleges/IRL for culture. Residual sample in the needle
and syringe used to collect the specimen can be used for smear
• MGIT to be used for culture. However, if MGIT is not available, LJ medium Diagnostic algorithm of NTEP to be
should be used followed in the Microbiology labs

MICROBIOLOGICAL GUIDANCE FOR COMMON TYPES OF EXTRAPULMONARY TUBERCULOSIS

• Sample: Tissue, pus, synovial fluid


OSTEOARTICULAR/
MUSCULOSKELETAL

• Sample amount: Biopsy: Specimen material 1 cm x 1 cm


biopsies. Any caseous area should be sampled. Add 0.5-2 ml Processing:
sterile saline to biopsy depending on its size to avoid drying of • Preferably immediately. If
tissue specimen not possible- store/transport
• Optimum fluid/pus: 2-3ml. at 2-8 0C
• Swabs are sub-optimal samples • If sample is adequate,
attempt molecular testing
at that site
PLEURAL

• Sample: Pleural fluid • If biopsy is not possible or at


• Sample amount: 10-15 ml an inaccessible site, refer
patient to the next higher
centre immediately where
appropriate test can be
MENINGITIS

• Sample: CSF: done


• Sample amount: 3-5 ml • If sample obtained at a
centre is inadequate, send
directly to nearest Tertiary
centre/medical colleges/IRL
• Sample: FNA/ Biopsy
LYMPHADENITIS

• Sample amount: Specimen material 1 cm x 1 cm biopsy. Add


0.5-2 ml sterile saline to biopsy depending on its size to avoid
drying of tissue specimen
• Optimum FNA sample: 2 ml
UROGENITAL

• Sample: urine
• Sample amount: Entire early morning urine sample
(3-5 days) Microbiological
procedures :
• AFB Smear Microscopy
FEMALE GENITAL

• Sample: Endometrial curettage/biopsy except in GI TB


• Sample amount: Biopsy: Specimen material 1cm x 1 cm • NAAT
biopsies. Any caseous area should be sampled. Add 0.5-2 ml
sterile saline to biopsy depending on its size to avoid drying • Culture (MGIT. If MGIT is not
of tissue specimen available LJ medium
should be used)
• Drug susceptibility testing,
• Sample: Tissue, pus, peritoneal fluid if culture is positive
GASTROINTESTINAL

• Sample amount: Biopsy: Specimen material 1 cm X 1 cm


biopsy (Atleast 6 biopsies for microbiological diagnosis
including any caseous area). Any caseous area should be
sampled. Add 0.5-2 ml sterile saline to biopsy depending on
its size to avoid drying of tissue specimen
• Optimum fluid/pus: 5-10ml

ABBREVIATIONS
ADA: Adenosine Deaminase FNA: Fine needle aspirate PHC: Primary health Centre
AFB: Acid fast bacilli LJ medium: Lowenstein Jensen medium TB: Tuberculosis
CHC: Community Health Centre MGIT: Mycobacteria Growth Indicator tube (Liquid culture medium for mycobacteria) IRL: Intermediate Reference
NAAT: Nucleic Acid Amplification Tests-Xpert MTB/RIF/TrueNat laboratory

REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for programme managers & Medical Officers. Ministry of Health & Family Welfare, Government of India.
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 15 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare, Government of India accessed
at https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 15 March, 2022.

This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) Guidelines for


DRUG SENSITIVE-TB TREATMENT AS PER NTEP
• For all TB patients whether being treated in public or private sector, clinicians should follow Standards for TB care in India guidelines
• In NTEP, the principle of TB treatment (except confirmed DR-TB) is to administer daily FDC of 1st line ATT in appropriate weight bands,
under direct observation
• For patients being treated in private sector, FDCs may be provided by NTEP whenever requested

Regimen for Drug-Sensitive TB cases: 2HRZE/4HRE


• This regimen is for H & R sensitive TB cases and cases where the sensitivity pattern can not be established
• Treatment is given in two phases:
1. Intensive phase consists of 8 weeks (56 doses) of isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E) given under
direct observation in daily dosages as per weight band categories
2. Continuation phase consists of 16 weeks (112 doses) of isoniazid, rifampicin and ethambutol in daily dosages. Only pyrazinamide
will be stopped in the continuation phase. The CP needs to be extended upto 24 weeks in certain forms of TB like CNS TB,
Skeletal TB. In disseminated TB or slow response treating physician may extend on case to case basis.
Regimen for DS-TB IP CP
Drugs 2 HRZE 4 HRE
Doses 56 112

ADULT TB TREATMENT
Drug dosages for first-line anti- TB drugs Special considerations for Adult TB Special considerations for Adult
Drugs Doses Meningitis abdominal TB
Isoniazid (H) 5 mg/kg daily (4 to 6 mg/kg) • Intensive Phase: 2 months of RHZE or • Extend duration of treatment in
Rifampicin (R) 10 mg/kg daily (8 to 12 mg/kg) RHZS cases of inadequate response
Pyrazinamide (Z) 25 mg/kg daily (20 to 30 mg/kg) • Continuation phase: 3 drugs-RHE for at • Refer for surgical management for
Ethambutol (E) 15 mg/kg daily (12 to 18 mg/kg) least 10 months*
complications [intestinal obstruction
Streptomycin (S)* 15 mg/kg daily (15 to 20 mg/kg) • STEROIDS (due to strictures), perforation]
*Streptomycin is administered only in certain situations, › Preferably Dexamethasone 0.4
• Consider endoscopic dilatation for
like TB meningitis or if any first line drug need to be mg/kg/day intravenously in 3-4
replaced due to ADR as per weight of the patient treatment for accessible strictures
divided doses during hospital stay
Pyridoxine may be given at a dosage of 10 mg per day • Refer for biliary drainage in case of
› If not feasible, give oral
Jaundice due to biliary obstruction
Number of tablets (FDCs) Dexamethasone 0.4 mg/kg/day in
divided doses or oral Prednisolone 1 (hepatobiliary obstruction/pancreatic
Intensive Phase Continuation
Weight H: 75mg; R: 150 TB)
Phase mg/kg/day in a single morning dose
category mg; Z: 400 mg; E: H: 75mg; R: 150 mg;
275 mg) › Discharge on oral steroids on tapering
E: 275 mg)
doses for total duration of 8-12 weeks Special considerations for
25 to 34 kg 2 2
› Regular follow up is essential every intra-ocular TB
35 to 49 kg 3 3
month for at least first 3 months & • ATT : 2 months of RHEZ + 7 months
50 to 64 kg 4 4 can be increased thereafter till of RH depending on clinical response
65 to 75 kg 5 5 treatment is stopped & side effects to treatment
> 75 kg 6 6 › Monitor liver function tests & any • Add pyridoxine 10 mg/day
other features of drug toxicity • Corticosteroids : Topical steroids eye
• Fixed Dose Combinations (FDCs) refer to products
containing two or more active ingredients in fixed drops for severe/anterior chamber
› Observe for clinical improvement or
doses, used for a particular indication(s) inflammation
any deterioration
• In NTEP, for Adults: 4-FDC (given in IP) consists of
• For treatment in children refer to
› Closely observe for development of
HRZE and 3-FDC (given in CP) consists of HRE paediatrician
any complications
• Systemic corticosteroids for severe
• During treatment if weight of the patient increases
by > 5 kg and crosses the next weight band *treatment duration may be increased in inflammation in consultation with
then patient should be given the next higher weight some cases as per the clinician decision Uveitits expert
band FDC drugs

PAEDIATRIC TB TREATMENT
• Paediatric cases are to be treated under NTEP in Special considerations for
Number of tablets (dispersible FDCs)
daily dosages as per 6 weight band categories paediatric osteoarticular TB
• Children & adolescents up to 18 years of age Intensive phase Continuation phase
Weight • Regimen : 2HRZE + 10HRE
weighing less than 39 kg, are to be treated using Band HRZ E HR E • Follow up every month during
paediatric weight bands. Those weighing 50/75/150 100
treatment & subsequently every
50/75 100
more than 39 kg to be treated with adult 3 months: Potts spine
weight bands. 4- 7 kg 1 1 1 1 with X-ray or MRI & Tubercular
8- 11 kg 2 2 dactylitis or arthritis with plain
Available paediatric dispersible FDCs and loose 2 2
X-ray
drugs 12 - 15 kg 3 3 3 3
1. Dispersible FDC, flavoured 16 - 24 kg 4 Special considerations for
4 4 4
• Rifampicin 75 mg + Isoniazid 50 mg + 3 + 1A * paediatric Abdominal TB
25 - 29 kg 3 3 + 1A * 3
Pyrazinamide 150 mg • Steroids- Not recommended
30- 39 kg 2 + 2A * 2 2 + 2A * 2
• Rifampicin 75 mg + Isoniazid 50 mg • Supportive treatment-
2. Dispersible Loose drugs • *A=Adult FDC (HRZE = 75/150/400/275; HRE = Management of SAM/Malnutrition
• Ethambutol 100 mg 75/150/275). It is added in higher weight band as per national guidelines
categories i.e. > 25 kg as these children may be able to
• Isoniazid 100 mg • Surgical treatment:
swallow tablets
• Pyridoxine may be given at a dosage of 10 mg per day › Acute intestinal obstruction,
Bowel perforation
Drug dosages for first-line anti- TB drugs Special considerations for paediatric TB › Persistence of obstructive
Isoniazid (H) 7-15 mg/kg meningitis symptoms despite conservative
(maximum dose 300 mg/day) ATT for paediatric TB Meningitis management & ATT
Rifampicin (R) 10-20 mg/kg › 2 HRZE and 10 HRE (in appropriate doses) • DO NOT start Empirical ATT with
(maximum dose 600 mg/day) Corticosteroids isolated:
› Prednisolone 2 mg/kg/day for 4 weeks & › Recurrent/Chronic abdominal
Pyrazinamide (Z) 30-40 mg/kg
then taper over 4 weeks* pain without danger signs
(maximum 2000 mg/day) › Slower taper needed in some patients
Ethambutol (E) 15-25 mg/kg › Chronic diarrhoea without
*Equivalent dose of another steroid formulation may
proper evaluation
(maximum 1500 mg/day) be used either injectable/oral

ABBREVIATIONS
ADR: Adverse drug reaction DR-TB: Drug resistant Tuberculosis H: Isoniazid R: Rifampicin
ATT: Anti-Tubercular treatment DS-TB: Drug sensitive Tuberculosis IP: Intensive phase S: Streptomycin
CNS: Central Nervous system E: Ethambutol MRI: Magnetic Resonance imaging TB: Tuberculosis SAM: Severe acute
malnutrition
CP: Continuation phase FDC: Fixed dose combination NTEP: National TB Elimination Programme
Z: Pyrazinamide
REFERENCES
1. National TB Elimination Programme, Central TB Division. Training modules for programme managers & Medical officers. Ministry of Health and Family Welfare, Government of India accessed at
https://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 on 24 February, 2022.
This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
March/ 2022

Department of Health Research


Ministry of Health and Family Welfare, Government of India

Standard Treatment Workflow (STW) for the Management of


ANTITUBERCULAR THERAPY RELATED HEPATITIS
PATIENT TO BE STARTED ON ATT START ATT
Diagnosis of ATT hepatitis Clinical symptoms
Risk factors for ATT Hepatitis present (abdominal pain, vomiting, unexplained
• History of underlying liver disease (jaundice, ascites, GI fatigue, yellowing of sclera, altered sensorium)
bleeding) • AST/ALT increased to 3 times of baseline/ULN
• Physical findings suggestive of liver disease
• Jaundice (Bilirubin 2 ULN)
(Splenomegaly, ascites, icterus, edema)
• Alcoholism No clinical symptoms
• Hypoalbuminemia and Malnutrition • AST/ALT increased to 5 times of baseline/ULN
• Elevated aminotransferases at baseline
Exclude viral hepatitis (HBsAg,
• HIV
Anti-HCV, IgM- antiHAV, IgM-AntiHEV,
• IV drug abuse Get PT/INR, Ultrasound liver
• Elderly age
Stop all hepatotoxic drugs
Yes • Need urgent ATT: Change to non-hepatotoxic
Evaluate for underlying liver disease No drugs (Fluroquinolones, ethambutol &
HBsAg, Anti-HCV, Ultrasound aminoglycosides)
Chronic Liver No CLD or • No need for urgent ATT: repeat LFT after a
disease + Cirrhosis week & reintroduce (see later)
• Non-resolution of LFT abnormalities: exclude
• Intensive education & counselling • Start ATT alternative causes of liver disease
• Modified ATT may be needed • Counsel about symptoms Jaundice and coagulopathy/encephalopathy
based on Child Pugh Status of ATT Hepatitis
• LFT monitoring • Refer to higher center immediately

Urgent ATT: life or organ No need for urgent REINTRODUCTION OF ATT HEPATOXIC DRUGS
threatening ATT • Reintroduce only if ALT and AST < 2 ULN & normal
• Sputum + Pulmonary TB • Sputum-ve Pulmonary TB bilirubin
• TB meningitis or CNS TB • TB lymphadenitis • Start one drug at time: helps identify the culprit
• Pericardial TB • Tubercular pleural • Rifampicin may be introduced at 10 mg/kg dose
• Any form that is life effusion • After one week add Isoniazid 5 mg/kg if LFT normal
threatening, eg., • Tubercular ascites • After one week add pyrazinamide 25 mg/kg if LFT is
Intestinal TB with • Intestinal TB normal
intestinal obstruction • Genitourinary TB • If ATT hepatitis severe (liver failure, coagulopathy or
• Ocular TB • Bone TB altered sensorium): Pyrazinamide reintroduction may
• Joint or Spinal TB be avoided
• Another approach could be low dose of one drug
followed by full dose after three days
• Duration of ATT: count only when full ATT is started

REINTRODUCTION OF ATT: IF AST AND ALT < 2 ULN


SEQUENTIAL INCREMENTAL

Initiate one at a time Rifampicin 10 mg/kg Initiate Rifampicin 150 mg/day


Gradually increase dose by day 4
1 week: repeat LFT
Initiate Isoniazid 100 mg/day at day 8
Initiate Isoniazid 5 mg/kg Gradually increase dose by day 11
1 week: repeat LFT
Initiate Pyrazinamide 500 mg/day on day 15
Initiate Pyrazinamide 25 mg/kg Gradually increase dose by day 18

CHILD PUGH (CTP) SCORE ATT SELECTION FOR UNDERLYING LIVER DISEASE
Score 1 Score 2 Score 3 Child Status Suggested ATT
Child A Cirrhosis 9 months of therapy with HRE OR
Bilirubin < 2 mg/dl 2-3 mg/dl >3 mg/dl (Score 1-6) 2 months of therapy with HRE followed
Albumin >3.5 gm/dl 2.8-3.5 gm/dl <2.8 gm/dl Stable Liver disease by 7 months of HR
Child B Cirrhosis One hepatotoxic drug regimen can be
INR <1.7 1.7-2.2 >2.2 used: Two months of therapy with INH
(Score 7-10)
Ascites Absent Moderate Advanced Liver (or) RIF with ETH & aminoglycoside,
Slight
Disease followed by 10 months of therapy with
Encephalopathy Absent Grade 1-2 Grade 3-4 INH/RIF & ETH
HEPATIC ENCEPHALOPATHY GRADE Child C Cirrhosis No hepatotoxic drug
• Grade 0: normal consciousness, personality & neurological (Score 11-15) 18 to 24 months treatment using a
examination Very advanced combination of ETH, FQL, cycloserine &
• Grade 1: restless, disturbances in sleep, irritability or liver disease aminoglycoside/ capreomycin
agitated, tremors, handwriting affected
In Acute hepatitis Avoid hepatotoxic drugs
• Grade 2: lethargy, disorientation to time, asterixis, ataxia
ATT with non-hepatotoxic drugs if urgent
• Grade 3: somnolent & stuporous, disoriented to place, ATT required
hyperactive reflexes, rigidity Wait till improvement in liver function if
• Grade 4: unrousable coma, decerebrate no urgent need of ATT

ABBREVIATIONS
ALT: Alanine transaminase GI: gastro-intestinal HRE: Isoniazid, Rifampicin, Pyrazinamide LFT: Liver function tests
AST: Aspartate transaminase HAV: Hepatitis A virus IgM: Immunoglobulin M PT: Prothrombin time
ATT: Anti-tubercular treatment HBsAg: Hepatitis B surface Antigen INH: Isoniazid RIF: Rifampicin
ETH: Ethambutol HCV: Hepatitis C virus INR: International normalized ratio TB: Tuberculosis
FQL: Fluoroquinolone HEV: Hepatitis E virus IV: Intravenous ULN: Upper limit of normal
REFERENCES
1. National TB Elimination Programme, Central TB Division. Training Modules for Programme Managers & Medical Officers. Ministry of Health & Family Welfare, Government of India
accesshttps://tbcindia.gov.in/index1.php?lang=1&level=1&sublinkid=5465&lid=3540 Last access on 17 March, 2022.
2. Guidelines for programmatic management of drug resistant tuberculosis in India March 2021. National TB Elimination Programme, Central TB Division, Ministry of Health & Family Welfare, Government of India
https://tbcindia.gov.in/showfile.php?lid=3590 Last access on 17 March, 2022.
3. Satsangi S., Randev S., Taneja S. (2022) Antitubercular Therapy-Related Hepatitis. In: Sharma V. (eds) Tuberculosis of the Gastrointestinal system. Springer, Singapore. https://doi.org/10.1007/978-981-16-9053-2_23
This STW has been prepared by national experts of India with feasibility considerations for various levels of healthcare system in the country. These broad guidelines are advisory, and are
based on expert opinions and available scientific evidence. There may be variations in the management of an individual patient based on his/her specific condition, as decided by the
treating physician. There will be no indemnity for direct or indirect consequences. Kindly visit our web portal (stw.icmr.org.in) for more information.
© Indian Council of Medical Research and Department of Health Research, Ministry of Health & Family Welfare, Government of India.
CONTRIBUTORS
Department of Health Research
Ministry of Health and Family Welfare, Government of India

PAEDIATRICS TB EXPERT GROUP


CHAIR
• Prof.
Sushil Kumar Kabra, Professor, Paediatrics, All India Institute of
Medical Sciences, New Delhi
CO-CHAIR
• Dr Varinder Singh, Director Professor, Paediatrics, Lady Hardinge
Medical College, New Delhi
MEMBERS*
• Dr Amber Kumar, Assistant Professor, Paediatrics, All India Institute of Medical
Sciences, Bhopal
• Dr Jagdish Prasad Goyal, Professor, Paediatrics, All India Institute of Medical
Sciences, Jodhpur
• Dr Joseph L Mathew, Professor, Paediatrics Pulmonology, Postgraduate
Institute of Medical Education and Research, Chandigarh
• Dr Kana Ram Jat, Additional Professor, Paediatrics, All India Institute of
Medical Sciences. New Delhi
• Dr Krishna Mohan Gulla, Associate Professor, Paediatrics, All India Institute of
Medical Sciences, Bhubaneswar
• Dr Manjula Datta, Chief Scientist, ASPIRE Chennai
• Dr Samriti Gupta, Assistant Professor, Paediatrics, All India Institute of Medical
Sciences, Bilaspur
• Dr Sangeeta Sharma, Professor, Paediatrics, National Institute of Tuberculosis
and Respiratory Diseases, New Delhi
• Dr Sarika Gupta, Professor (J.Gr.), Department of Paediatrics, King George's
Medical University, Lucknow
• Dr Tanu Singhal, Consultant, Paediatrics Infectious Disease, Kokilaben
Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai
*
Arranged in alphabetical order by name.
Department of Health Research

EXTRAPULMONARY TB EXPERT GROUP


Ministry of Health and Family Welfare, Government of India

CHAIR
• Dr Dhruva Chaudhry, Sr Professor & Head, Pulmonary & Critical Care
Medicine, Pandit Bhagwat Dayal Sharma Post Graduate Institute of
Medical Sciences, Rohtak
CO-CHAIR
• Dr Ashutosh N Aggarwal, Professor & Head, Pulmonary Medicine,
Postgraduate Institute of Medical Education and Research, Chandigarh
MEMBERS*
• Dr Anil Kumar Jain, Professor, Orthopedics, University College of Medical
Sciences, New Delhi
• Dr Ashwani Khanna, Former State TB Officer and Consultant, National
Tuberculosis Elimination Program, Govt of India, New Delhi
• Dr Camilla Rodrigues, Consultant Microbiologist, Parmanand Deepchand
Hinduja and Medical Research Centre, Mumbai
• Dr Jai Bhagwan Sharma, Professor, Obstetrics and Gynaecology, All India
Institute of Medical Sciences, New Delhi
• Dr Jyotirmay Biswas, Director, Uveitis & Ocular Pathology Department,
Sankara Nethralaya, Chennai
• Dr Kusum Sharma, Associate Professor, Medical Microbiology,
Postgraduate Institute of Medical Education and Research, Chandigarh
• Dr Mandira Varma-Basil, Professor, Microbiology, Vallabhbhai Patel Chest
Institute, University of Delhi, Delhi
• Dr Manish Modi, Professor, Neurology, Postgraduate Institute of Medical
Education and Research, Chandigarh
• Dr Manjula Datta, Chief Scientist, ASPIRE Chennai
• Dr Narayan Jana, Professor & Head, Obstetrics and Gynaecology,
Chittaranjan Seva Sadan College of Obstetrics, Gynaecology and Child
Health, Kolkata
� Dr Nitish Naik, Professor, Cardiology, All India Institute of Medical Sciences,
New Delhi
• Dr Priscilla Rupali, Professor, Infectious Diseases, Christian Medical College,
Vellore
• Dr Rajesh Malhotra, Professor, Orthopedics, All India Institute of Medical
Sciences, New Delhi
• Dr Ramprasad Dey, Professor, Obstetrics and Gynaecology, Chittaranjan
Seva Sadan College of Obstetrics, Gynaecology and Child Health, Kolkata
• Dr Ritesh Aggarwal, Professor, Pulmonary Medicine, Postgraduate Institute
of Medical Education and Research, Chandigarh
Department of Health Research
Ministry of Health and Family Welfare, Government of India

• Dr Rohit Bhatia, Professor, Neurology, All India Institute of Medical


Sciences, New Delhi
• Dr Roy Thankachen, Professor, Cardio-thoracic and Vascular Surgery,
Christian Medical College Vellore
• Dr Sambit N Bhattacharya, Director Principal, Dr Baba Saheb Ambedkar
Medical College & Hospital, Delhi
• Dr Thangakunam Balamugesh, Professor, Pulmonary Medicine, Christian
Medical College, Vellore
• Dr Uday Pratap Singh, Associate Professor, Urology, Sanjay Gandhi
Postgraduate Institute of Medical Sciences, Lucknow, India
• Dr V Ramesh, Professor, Employees' State Insurance Corporation Medical
College and Hospital, Faridabad
• Dr Vineet Ahuja, Professor, Gastroenterology, All India Institute of Medical
Sciences, New Delhi
• Dr Vishal Sharma, Associate Professor, Gastroenterology, Postgraduate
Institute of Medical Education and Research, Chandigarh
• Dr Vishali Gupta, Professor, Advanced Eye Centre, Postgraduate Institute of
Medical Education and Research, Chandigarh
*
Arranged in alphabetical order by name.

EDITORIAL COMMITTEE
• Dr Manjula Singh, Scientist F, ICMR, New Delhi
• Dr Ashoo Grover, Scientist F, ICMR, New Delhi
• Dr Lokesh Kumar Sharma, Scientist E, ICMR, New Delhi
• Dr Sudipto Pallab Roy, Scientist E, ICMR, New Delhi
• Dr Saumya Srivastava Aggarwal, Scientist C, ICMR, New Delhi
• Ms Saumya Deol, Scientist B, ICMR, New Delhi
CHIEF PATRON
Department of Health Research
Ministry of Health and Family Welfare, Government of India

Dr Mansukh Mandaviya
Union Minister for Health & Family Welfare

PATRON
Dr Bharati Pravin Pawar
Minister of State for Health & Family Welfare

ADVISORS
Prof. Dr Balram Bhargava,
Secretary, DHR & Director General, ICMR

Dr Samiran Panda,
Additional Director General, ICMR

ICMR COORDINATING UNIT


Epidemiology and Communicable Diseases- TB Unit
Dr A M Khan Scientist G, ICMR, New Delhi
Dr Manjula Singh, Scientist F, ICMR, New Delhi.
Dr Sudipto Pallab Roy, Scientist E, ICMR, New Delhi
Ms Saumya Deol, Scientist B, ICMR, New Delhi
Dr Sneh Shalini, Technical Officer B, ICMR, New Delhi

ICMR STW TEAM


Dr R S Dhaliwal, Scientist G & Head(NCD), ICMR, New Delhi
Dr Ashoo Grover, Scientist F, ICMR, New Delhi
Dr Lokesh Kumar Sharma, Scientist E, ICMR, New Delhi
Dr Jerin Jose Cherian, Scientist D, ICMR, New Delhi
Mr Neeraj Parmar, Technical Officer A, ICMR, New Delhi
Dr Saumya Srivastava Aggarwal, Scientist C, ICMR, New Delhi
Mr Dhiraj Kumar, Graphics Designer, ICMR, New Delhi

CENTRAL TB DIVISION, MOHFW


Dr Rajendra Prasad Joshi, Deputy Director General
Dr Sanjay Kumar Mattoo, Joint Director

ADMINISTRATIVE SUPPORT
Mr Mahesh Chand, Sr Administrative Officer, ICMR, New Delhi
Mrs Harjeet Bajaj, Administrative Officer, ICMR, New Delhi
Mr Anil Lakhera, Section Officer, ICMR, New Delhi
Ms Ankita Bhakuni, Project Officer, ICMR, New Delhi
Mr Neeraj Kumar, Data Entry Operator, ICMR, New Delhi
Department of Health Research
Ministry of Health and Family Welfare, Government of India

STANDARD TREATMENT
WORKFLOWS of India

S PE C I A L E D I T I O N O N PA E D I AT R I C A N D
PARTNER EXTRAPULMONARY TUBERCULOSIS 2022

Central TB Division
Ministry of Health and Family Welfare
Government of India

You might also like