Date :15 t h October,2012

From,
Dr. Aniketh.Vijay.B,
Junior resident / PG,
Department of Medicine,
A.J.Institute of Medical Sciences,
Kuntikana, Mangalore.

To,
The Registrar,
RGUHS,4TH T Block,
Jayanagar,
Bangalore-560041.

Through the Head of the department of Medicine

Subject: Submission of synopsis of dissertation to the Registrar,RGUHS.

I am hereby submitting my MD dissertation synopsis titled “A COMPREHENSIVE

STUDY ON THE INCIDENCE OF URINARY TRACT INFECTIONS,ORGANISMS
CAUSING IT AND ANTIBIOTIC SUSCEPTIBILITY IN PATIENTS WITH
DIABETES MELLITUS IN AJIMS,MLORE” for the registration of dissertation to Rajiv
Gandhi University of Health Sciences, Blore. I request you to kindly do the needful.

Thanking you,
Yours sincerely

Dr. Aniketh.Vijay.B

1
 Proforma to be filled by the Principal Investigator (PI) for
submission to Institutional Ethics Committee (IEC)
(for attachment to each copy of the proposal)

Serial No of IEC
Management Office:

Proposal Title: “A COMPREHENSIVE STUDY ON THE INCIDENCE OF URINARY

TRACT INFECTIONS,ORGANISMS CAUSING IT AND ANTIBIOTIC
SUSCEPTIBILITY IN PATIENTS WITH DIABETES MELLITUS IN
AJIMS,MLORE”.

Name, Designation Address

Signature
& Tel & Fax Nos.
Qualifications Email ID

Principal Dr. Aniketh.Vijay.B, S/O Dr.D.L.Vijay kumar,

Investigator Junior Resident, Ashraya Hospital , Naidu
Dept.of Medicine street,p.b.no-
A.J.Institute of Medical 77,Chikmagalur-577101
Sciences. Ph-8762577777
Email-
M.B.B.S. aniketh.vijay7@gmail.com

Dr.Devdas rai, Capital

Guide Professor apartments,apartment
Dept. of Medicine no.302,kadri toll
A.J.Institute of Medical gate,Nantoor,Mangalore-
Sciences. 575003
Ph-9845081145
M.B.B.S, M.D.(General 0824-2213762
Medicine) Email-
drdevdasrai@gmail.com

Curriculum Vitae of principal investigator and the guide (with subject specific publications
limited to previous 5 years) – attached
1.Type of Study: A two year prospective study

2
2: Brief description of the proposal: Diabetes mellitus has long been considered to be a
predisposing factor for uti. Urinary tract is the principal site of infection in DM. UTI in diabetics
can cause severe complications ranging from dysuria,urethritis,cystitis,pyelonephritis and organ
damage.With an estimated 50.8 million people living with diabetes,india is considered as the
diabetic capital of the world.Therefore the present study is being undertaken to determine the
incidence of uti,organisms causing it and antibiotic susceptibility in pts with DM.
3. Subject selection:
i. Number of Subjects : 300
ii. Duration of study : 2 years
iii. Will subjects from both sexes be recruited: YES
iv. Inclusion / exclusion criteria given: YES

v. Type of subjects: Pts with type 1 and type 2 DM having symptomatic or

asymptomatic bacteriuria from A J Institute of Medical Sciences as study group.

4. Privacy and confidentiality

Confidential handling of data : Yes
5. Consent : Please find it attached - written informed consent
i. Consent form : (included elements)

1. Understandable language
2. Statement that study involves research
3. Statement that consent is voluntary
4. Purpose and procedures
5. Risks & Discomforts
6. Benefits
7. Confidentiality of records
8. Right to withdraw
9. Contact information
ii. Who will obtain consent – Principal investigator
6. Will any advertising be done for recruitment of Subjects?
(posters, flyers, brochure, websites – if so kindly attach a copy) No
7. Risks & Benefits: No risks, but benefits to the research world
8. Is there compensation for participation? No
Checklist for attached documents:
1. Project proposal – 2 Copies
2. Curriculum Vitae of Investigators
3. Curriculum Vitae of Guide
4. Informed Consent form
5. Copy of data collection Proforma

Place: Signature & Designation of

Date: Principal investigator

3
 CURRICULUM VITAE

Name : Dr.Aniketh.Vijay. B
Date of Birth &Age : June 17th ,1987 - 25years
Present Designation : PG/Junior Resident
Department : General medicine.
College : A. J. Institute of Medical Sciences
City : Mangalore
Residential address :, S/o Dr.D.L.Vijay kumar,
Ashraya Hospital,
Naidu street,p.b.no 77,
Chikmagalur-577101

.
Phone & fax number with code: Office: 08262-231171
Residence: -
Email address : aniketh.vijay7@gmail.com
Mobile Number : 8762577777
PAN Number : AIRPA7632H
Qualification:
Qualification College University Year Registration Name of the
number of UG state Medical
& PG with date Council
MBBS SDM COLLEGE RAJIV Augus 93311 KARNATAKA
OF MEDICAL GANDHI t 2005 24.10.2011 MEDICAL
SCIENCES AND UNIVERS COUNCIL
HOSPITAL. ITY OF
HEALTH
SCIENCE

Details of the previous appointments/ teaching experience:

Designatio Department Name of From To Total

n Institution DD/MM/YY DD/MM/YY experience in
years and
months
PG/ Jr. General A. J. Institute of May 23rd, Till Date
Resident medicine Medical Sciences, 2012
Mangalore

4
 CURRICULAM VITAE
Name : DR. B.DEVDAS.RAI
Date of Birth & Age : 30 APRIL, 1962, 50 years
Present Designation : Professor
Department : GENERAL MEDICINE
College A.J. Institute of Medical Sciences
City : Mangalore
Residential Address : Capital apartments, apartment no 302,
Kadri toll gate,Nantoor,Mangalore
- 575003.

Phone & Fax Number with code Office : 0824-2225533

Residence : 0824-2213762
E- Mail id : drdevdasrai@gmail.com
Mobile Number : 9845081145
PAN Number : ABQPR0081D
1.(i) Date of joining Present Institution :APRIL 29, 2008 as Professor
Qualifications:
Qualification College University Year Registration Name of
No.of UG & the State
PG with Date Medical
Council
MBBS KMC MANGALORE MARCH 26489, Karnataka
MANIPAL University 1987 SEPTEMBER medical
18, 1987 Council
MD(MEDICINE) JNMC KARNATAKA FEB 26489 Karnataka
BELGAUM University 1993 SEPTEMBER Medical
18, 1987 Council

Details of the previous appointments/teaching experience

Designation Departmen Name of Institution From To Total
t DD/MM/Y DD/MM/Y Experience in
Y Y years&
months
TUTOR/ MEDICIN JULY 1988 AUGUST 3 years
RESIDENT E JNMC, BELGAUM 1991

Assistant MEDICIN K S HEGDE 1-1-1999 31-12-2003 5 YEARS

Professor E MEDICAL
COLLEGE,MLORE
Associate MEDICIN K S HEGDE 1-1-2004 31-12-2007 4 years
Professor E MEDICAL
COLLEGE,MLORE
MEDICIN K S HEGDE 1-1-2008 28-04-2008 4 MONTHS
Professor E MEDICAL
COLLEGE,MLORE

PROFESSO MEDICINE AJ 29-04-2008 MAY 22ND 4 YEARS 23

5
R INSTITUTE 2012 DAYS
OF
MEDICAL
SCIENCES,
MANGALOR
E

6
 SYNOPSIS
Submission for ethical clearance to Ethical Committee of AJIMS

“A COMPREHENSIVE STUDY ON THE INCIDENCE OF URINARY TRACT

INFECTIONS,ORGANISMS CAUSING IT AND ANTIBIOTIC

SUSCEPTIBILITY IN PATIENTS WITH DIABETES MELLITUS IN

AJIMS,MLORE”

Name of the candidate : Dr. Aniketh Vijay B

Guide : Dr. Devdas Rai

Course and Subject : M.D. General Medicine

Department of Medicine,

A.J. INSTITUTE OF MEDICAL SCIENCES,

Kuntikana, Mangalore – 575004

2012

7
1. Name of the candidate Dr. Aniketh Vijay B,
& address: POSTGRADUATE STUDENT,
DEPT. OF MEDICINE,
(in block letters)
AJ INSTITUTE OF MEDICAL SCIENCES,
NH-17, KUNTIKANA,
MANGALORE–575004.

AJ INSTITUTE OF MEDICAL SCIENCES,

2. Name of the Institute: NH-17, KUNTIKANA,
MANGALORE – 575004.

3. Course of study and Subject: M.D.GENERAL MEDICINE

4. Date of admission to course: 23 r d may, 2012

5.Title of the Topic:“ A COMPREHENSIVE STUDY ON THE INCIDENCE

OF URINARY TRACT INFECTIONS,ORGANISMS CAUSING IT AND

ANTIBIOTIC SUSCEPTIBILITY IN PATIENTS WITH DIABETES MELLITUS

IN AJIMS, MLORE”

8
BRIEF RESUME OF THE INTENDED WORK:

6.1 Need for the study:

Diabetes has long been considered to be a predisposing factor for UTI. Urinary tract is the
principal site of infection in DM. UTI in diabetics can cause severe complications ranging
from dysuria,urethritis,cystitis,pyelonephritis and organ damage. With an estimated 50.8
million people living with diabetes mellitus,india is considered as the diabetic capital of the
world. Therefore the present study is being undertaken to determine the incidence of
UTI,organisms causing it and antibiotic susceptibility in pts with DM.

6.2Review of literature:

Janifer j and V Vishwanathan did a study on the prevalence of UTI in south Indian diabetics
and was published in Indian journal of nephrology 2009,july and found that UTI was more
common in diabetics than non diabetics and women were more prone and gram negative
organisms like e.coli,klebsiella were the main pathogens and were highly sensitive to
9
cefoperazone/sulbactam and also to piperacillin/tazobactam .

Md.hamza and Lovely barai from the department of microbiology,Bangladesh institute of

research and rehabilitation for diabetes,endocrine and metabolic disorders,Dhaka did a study
on the pattern of organisms causing UTI in diabetics and found that gram negative organisms
like klebsiella,pseudomonas were the predominant pathogens and were mainly sensitive to
10
ampicillin,imipenem ,amikacin .

9
6.3Objectives of the study:

• To know the incidence of UTI in Patients with DM.

• To know the organisms most commonly involved in causing UTI in pts

with DM.

• To know the antibiotic susceptibility of the organisms causing UTI in

pts with DM.

7. Material and methods:

Source of Data: Hospital based study

Method of collection of data: 300 patients will be enrolled for study after

obtaining an informed consent.

Patients coming to AJIMS general medicine opd and ward having diabetes

mellitus with symptomatic or asymptomatic bacteriuria.

Study design : Prospective study

Sample size : 300

Sample: Patients attending AJ Institute of Medical Sciences

Place: A.J. Institute of medical sciences , Mangalore - 575004

Sample and sampling technique : Sample size- 300

Sampling technique- randomized controlled trial.
Study type: Prospective Study

Inclusion criteria:

1.Pts with type 1 DM {known cases on treatment as well as recently detected cases}.

10
2. Pts with type 2 DM{known cases on treatment as well as recently detected cases}.

3. Pts with DM having symptomatic or asymptomatic bacteriuria {males-- urinary cultures

showing > 103 CFU/ML , and in females—urinary cultures showing >105 CFU/ML}.

Exclusion criteria:
1. HIV possitive individuals.

2. Diabetic patients who are known cases of obstructive uropathy.

3. Bedridden patients with DM in whom regular catheterisation is being done.

4. Gestational diabetes mellitus.

11
Plan for data analysis: Data will be entered in Microsoft Excel sheet and will be analysed
using SPSS version 11.0 statistical software. Data will be depicted in the form of tables and
charts. Appropriate statistical tests like Chi Square test and other non parametric tests will be
used.

7.3 Does the study require any investigations or interventions to be

conducted on patients or other humans or animals? If so, please describe

briefly.

Yes, the study requires the following;

-RBS,PPBS,FBS,HBA1C

-URINE ROUTINE ANALYSIS

-URINE MICROSCOPY

-URINE CULTURE/SENSITIVITY

-USG ABDOMEN AND PELVIS

-UREA,CREATININE

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

Awaited

12
8. References:

1 . Walter ES, Braunald E, editor. Urinary tract infection and pyelonephritis. Harrisons
principles of Internal Medicine , 15th edition, edited by -2001; vol.2 :1620 – 26

2 . Stepleton A. Urinary tract infections in patients with diabetes. American Journal of

Medicine. 2002; 113: 80 – 84

3 . Pozzilli P , Lesile RD. Infections, immunity, and diabetes. International textbook of

diabetes mellitus. { 3rd edition } 2004; vol. 2: 1729 – 39

4. Bryan CS , Reynolds KL , Metzger WT . Bacteremia in diabetic patients : comparison

of incidence and mortality with non diabetic patients. Diabetic care.1985; 8: 244-249

5 . Foxman B. Epidemiology of urinary tract infections: incidence ,morbidity and

economic costs, dis. mon. 2003; 49: 53 – 70

6 . Bending J, Schrier R ,editor. The kidney and renal tract. Diabetes: clinical
management 8th edition. 1990: 286-7, chap - 25

7 . World Health Organisation . Part 1: diagnoses and classification of diabetes mellitus-

defn,diagnoses,classification,complications. Geneva: dept of non communicable disease
surveillance, WHO; 1999.

8 . Wheat LJ . Infection and diabetes mellitus. Diabetic care. 1980; 3: 187 – 97

9.Janifer J and V Vishwanathan . A study on the prevalence of UTI in south indian

diabetics . Indian Journal of Nephrology. 2009, july ; 107-111 .

10.Md Hamza and Lovely Barai .A study on the pattern of organisms causing uti in
diabetics , Dept of Microbiology, Bangaladesh Institute of research and rehabilitation for
diabetic ,endocrine and metabollic disorders ,Dhaka ,Bangladesh . Journal of Medical
Microbiology. 2010;06(04); 6 – 8.

13
9. Signature of the candidate :

10. Remarks of the guide

11.Name and Designation of (in block letters):-

11.1 Guide: Dr. DEVDAS RAI, M.D.
PROFESSOR
DEPT.OF MEDICINE
A J INSTITUTE OF MEDICAL SCIENCES
11.2 Signature:

11.3Co-Guide: Dr. RAGHAVENDRA NAYAK

CONSULTANT NEPHROLOGIST
DEPT. OF NEPHROLOGY
A J INSTITUTE OF MEDICAL SCIENCES

11.4 Signature:

11.5 Head of Department: Dr. EVS MABEN M.D.

PROFESSOR& HEAD
DEPT.OF MEDICINE
A J INSTITUTE OF MEDICAL SCIENCES
11.6 Signature:

12. Remarks of the Chairman and Principal:

12.2Signature:

14
 PROFORMA

A COMPREHENSIVE STUDY ON THE

INCIDENCE OF UTI, ORGANISMS CAUSING IT
AND ANTIBIOTIC SUSCEPTIBILITY IN PTS
WITH DIABETES MELLITUS IN AJIMS,
MLORE

FORMAT OF PATIENT EXAMINATION

1. Case No. 2. I.P.No.

3. Patient’s Name 4. Age

5. Gender - 6. Occupation

7. Address

CHIEF COMPLAINT

History of burning micturition since days/months

History of fever with chills since days/months

HISTORY OF PRESENTING ILLNESS

Burning micturition since days/ months

Fever with chills since days/months

History of :-

a) Increased frequency of micturition + / -

b) Increased appetite + / -

c) Increased thirst + / -

15
 d) Generalized weakness + / -

PAST HISTORY

History of diabetes mellitus + / -

If present, then since days/months

FAMILY HISTORY

PERSONAL HISTORY

GENERAL EXAMINATION :

State of nutrition & built

PALLOR / ICTERUS / CLUBBING / CYANOSIS / EDEMA /

LYMPHADENOPATHY

TEMPERATURE:
BP : RR:
PR :

16
1.EXAMINATION OF ABDOMEN :

2.EXAMINATION OF RESPIRATORY SYSTEM :

3.EXAMINATION OF CARDIOVASCULAR SYSTEM :

4.EXAMINATION OF CENTRAL NERVOUS SYSTEM :

17
DATA COLLECTION SYSTEM:

1.DATA COLLECTION TABLE:

RBS
FBS
PPBS
HBA1C
B.UREA
S.CREATININE
Hb
ESR

2.URINE ROUTINE:

PHYSICAL PROPERTIES— COLOUR

ODOUR
APPEARANCE
SPECIFIC GRAVITY
CHEMICAL PROPERTIES—PROTEIN
SUGAR
KETONE BODIES
UROBILINOGEN
BILE ACIDS AND BILE SALTS

3.URINE MICROSCOPY: RBC

WBC/PUS CELLS
EPITHELIAL CELLS
CRYSTALS
CASTS
BACTERIA

4.URINE CULTURE/SENSITIVITY: ORGANISM/BACTERIA

COUNTS IN CFU/ML
ANTIBIOTIC SENSITIVITY

18
19
 Written Informed Consent Form

A J INSTITUTE OF MEDICAL SCIENCES,

KUNTIKANA, MANGALORE.

Informed consent form for the volunteers at “A J Institute of Medical Sciences,

Kuntikana, Mangalore”, who will be participating in the research project (MD
dissertation) entitled : “A COMPREHENSIVE STUDY ON THE INCIDENCE
OF URINARY TRACT INFECTIONS,ORGANISMS CAUSING IT AND
ANTIBIOTIC SUSCEPTIBILITY IN PATIENTS WITH DIABETES
MELLITUS IN AJIMS, MLORE”.

Name of Principal Investigator Dr.ANIKETH.VIJAY.B,

Postgraduate student.

Name of Organization Department of Medicine,

A J Institute of Medical Sciences,
Kuntikana, Mangalore

This Informed Consent Form has two parts:

 Information Sheet (to share information about the research with you)
 Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

20
 PART I: Information Sheet

Introduction

I, Dr. ANIKETH. VIJAY. B, postgraduate student in the Department of

Medicine, A J Institute of Medical Sciences, Kuntikana, Mangalore, am
working on my MD dissertation titled “A COMPREHENSIVE STUDY ON
THE INCIDENCE OF URINARY TRACT INFECTIONS,ORGANISMS
CAUSING IT AND ANTIBIOTIC SUSCEPTIBILITY IN PATIENTS
WITH DIABETES MELLITUS IN AJIMS, MLORE”.

I am going to give you information and invite you to be part of this research.
You do not have to decide today whether or not you will participate in the
research. Before you decide, you can talk to anyone you feel comfortable with
about the research.

There may be some words that you do not understand. Please ask me to stop as
we go through the information and I will take time to explain. If you have
questions later, you can ask them and get yourself clarified.

Purpose of the research

Diabetes has long been considered to be a predisposing factor for UTI. Urinary tract is the
principal site of infection in DM. UTI in diabetics can cause severe complications ranging
from dysuria,urethritis,cystitis,pyelonephritis and organ damage. With an estimated 50.8
million people living with diabetes mellitus,india is considered as the diabetic capital of the
world. Therefore the present study is being undertaken to determine the incidence of
UTI,organisms causing it and antibiotic susceptibility in pts with DM.

Type of Research Intervention

Patients’ blood sample is sent for estimation of RBS,FBS,PPBS levels.

Patients urine sample is sent for urine routine analysis,urine microscopy and
urine culture/sensitivity.

21
Participant selection

Patients with diabetes mellitus , type 1/ type 2 who present with

symptomatic or asymptomatic bacteruria ,coming to general medicine opd
or admitted in AJIMS general medicine ward.

Inclusion criteria:

1.Pts with type 1 DM {known cases on treatment as well as recently detected cases}.

2.Pts with type 2 DM{known cases on treatment as well as recently detected cases}.

3. Pts with DM having symptomatic or asymptomatic bacteriuria {males urinary cultures

showing > 103 CFU/ML , and in females showing >105 CFU/ML.

Exclusion criteria:
1. HIV possitive individuals.

2. Diabetic patients who are known cases of obstructive uropathy.

3. Bedridden patients with DM in whom regular catheterisation is being done.

4. Gestational diabetes mellitus.

22
Procedures and Protocol
RBS,FBS,PPBS,URINE--
ROUTINE,MICROSCOPY,CULTURE/SENSITIVITY will be done for all the
participants.

Voluntary Participation

Your participation in this research is entirely voluntary. It is your choice

whether to participate or not. Whether you choose to participate or not, it will
not affect your patient’s treatment process.

Benefits
Personally you might be or may not be benefited in any way directly from the
research. But by taking part in this research, you will be helping the scientific
community to learn more about the incidence of UTI IN PTS WITH DIABETS
MELLITUS.

Reimbursements

You won’t be given any monetary incentives or gifts for being a part of this
research.

Confidentiality

The information that we collect from this research project will be kept
confidential. Information about the patient that will be collected during the
research will be put away and no-one but the researchers will be able to see it.
Any information about the patient will have a number on it instead of your
name.

Sharing the Results

The knowledge that we get from doing this research will be shared with you.
Confidential information will not be shared. We will publish the results in order
that other interested people may learn from our research.

23
Right to Refuse or Withdraw

You do not have to take part in this research if you do not wish to do so. You
may also stop participating in the research at any time you choose. It is your
choice and all of your rights will still be respected.

Who to Contact

This proposal has been reviewed and approved by the Research and Ethical
committee of A J institute of Medical Science, Kuntikana Mangalore, which is a
committee whose task it is to make sure that research participants are protected
from harm. You may contact the following member of the Institute Ethics
committee for more details

Dr. ANIKETH.VIJAY.B

Dr. DEVDAS.RAI

You can ask me any more questions about any part of the research study, if you
wish to. Do you have any questions?

24
 PART II: Certificate of Consent

I have read the foregoing information, or it has been read to me. I have had the
opportunity to ask questions about it and any questions that I have asked have
been answered to my satisfaction. I consent voluntarily to participate as a
participant in this research.

Name of Participant_________________________
Signature of Participant ___________________
Date __________________________________
Day/month/year

If illiterate a literate witness must sign (if possible, this person should be
selected by the participant and should have no connection to the research
team). Participants who are illiterate should include their thumb-print as well.

I have witnessed the accurate reading of the consent form to the potential
participant, and the individual has had the opportunity to ask questions. I
confirm that the individual has given consent freely.

Name of witness_________________ Thumb print of participant

Signature of witness _____________

Date ________________________
Day/month/year

25
Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant, and
to the best of my ability made sure that the participant understands that the
following will be done:
1. FBS,PPBS
2. RBS
3. HBA1C
4. Hb,ESR
5. Urea, Creatinine
6. URINE-ROUTINE,MICROSCOPY,CULYURE/SENSITIVITY
I confirm that the participant was given an opportunity to ask questions about
the study, and all the questions asked by the participant have been answered
correctly and to the best of my ability. I confirm that the individual has not been
coerced into giving consent, and the consent has been given freely and
voluntarily.
  
 A copy of this informed consent from has been provided to the participant.

Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent_____________________

Date ___________________________
Day/month/year

26