| CTRI Number |
CTRI/2025/12/099530 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Common Germs and Antibiotic Effectiveness in Urinary Tract Infections (UTIs) in Northwest India |
|
Scientific Title of Study
|
Antibiotic susceptibility pattern and bacteriological profiling of uropathogens causing urinary tract infection in a tertiary care hospital of Northwestern India: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashu Garg |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Junior Resident, Room no. 11, Department of Pharmacology, Government Medical College, Patiala (147001), Punjab, India
Patiala
PUNJAB
147001
India |
| Phone |
9888307650 |
| Fax |
|
| Email |
gargashu512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasbir Singh |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College, Patiala |
| Address |
Professor and Head, Room No. 1, Department of Pharmacology, Government Medical College, Patiala (147001), Punjab, India
Patiala
PUNJAB
147001
India |
| Phone |
9417212020 |
| Fax |
|
| Email |
jsjasbir9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashu Garg |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College, Patiala |
| Address |
Junior Resident, Room no. 11, Department of Pharmacology, Government Medical College, Patiala (147001), Punjab, India
Patiala
PUNJAB
147001
India |
| Phone |
9888307650 |
| Fax |
|
| Email |
gargashu512@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Microbiology, Government Medical College, Patiala (147001), Punjab, India |
|
|
Primary Sponsor
|
| Name |
Government Medical College Patiala |
| Address |
Government Medical College, Patiala (147001), Punjab, India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashu Garg |
Government Medical College, Patiala |
Room No. 138, Bacteriology Lab, Department of Microbiology
Patiala
PUNJAB |
09888307650
gargashu512@gmail.com |
| Dr Ashu Garg |
Government Medical College, Patiala |
Junior Resident, Room No. 11, Department of Pharmacology
Patiala
PUNJAB |
09888307650
gargashu512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GMC, Patiala |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.99 Year(s) |
| Gender |
Both |
| Details |
1. Urinary samples with significant bacteriuria.
2. Urine culture reports positive for bacterial uropathogens regardless of age, gender, ethnicity, or nationality.
|
|
| ExclusionCriteria |
| Details |
1. Urine culture reports positive for polymicrobial infections involving more than two bacterial species.
2. Urine culture reports positive for uropathogens of non-bacterial aetiology, either as the sole pathogen or in combination with bacteria.
3. Urinary samples with bacteriuria less than 105 CFU/ml. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the prevalence of different types of bacteria causing urinary tract infection. |
2-4 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the current antibiotic susceptibility patterns of bacterial isolates causing urinary tract infection. |
2-4 Days |
|
|
Target Sample Size
|
Total Sample Size="340"
Sample Size from India="340"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ABSTRACT
Introduction:
Urinary tract infection (UTI) is known as bacterial growth in the typically
sterile urinary tract (kidney and/or bladder). UTIs are among the most common
bacterial infections encountered in clinical practice, with their causative
agents and antimicrobial susceptibility patterns varying by region and over
time.
Aim: To
study the prevalence and current antibiotic susceptibility patterns of
different types of bacteria causing urinary tract infection.
Materials
and Methods: An observational, cross-sectional study will
be conducted at Government Medical College and Hospital, Patiala, Punjab.
Randomized data of 340 urine culture and antimicrobial sensitivity reports will
be taken from the Department of Microbiology. The observations will be recorded
as per the Performa attached and will be subjected to statistical analysis, and
compare with the data already available in accessible literature.
Clinical
Significance: The findings from this study will provide updated insights into the
regional epidemiology of uropathogens and their resistance profiles, aiding in
the formulation of effective empirical treatment strategies and antibiotic
policies. |