CTRI

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CTRI Number

CTRI/2025/06/089103 [Registered on: 18/06/2025] Trial Registered Prospectively

Last Modified On:

01/06/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Study on Common Bacteria Found in Urine Samples and How They Respond to Antibiotic Treatment in Patients with Urinary Tract Infections

Scientific Title of Study

Spectrum of bacterial isolates from urine samples and their antibiotic sensitivity patterns.

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 Chandrasekar M
Designation	Professor
Affiliation	Galgotias University, Greater Noida, Uttar Pradesh
Address	Department of Medical Laboratory Technology, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 203201 India Gautam Buddha Nagar UTTAR PRADESH 203201 India
Phone	8015185002
Fax
Email	shekarmlt09@hotmail.com

Details of Contact Person
Scientific Query

Name	KASHIF RAZA
Designation	Research Scholar
Affiliation	Galgotias University, Greater Noida, Uttar Pradesh
Address	Department of Medical Laboratory Technology, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 203201 India Gautam Buddha Nagar UTTAR PRADESH 203201 India
Phone	7739177333
Fax
Email	kashif.sm684@gmail.com

Details of Contact Person
Public Query

Name	KASHIF RAZA
Designation	Research Scholar
Affiliation	Galgotias University, Greater Noida, Uttar Pradesh
Address	Department of Medical Laboratory Technology, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 203201 India Gautam Buddha Nagar UTTAR PRADESH 203201 India
Phone	7739177333
Fax
Email	kashif.sm684@gmail.com

Source of Monetary or Material Support

Galgotias University, Greater Noida, Uttar Pradesh

Primary Sponsor

Name	Dr Chandrasekar M
Address	Galgotias University, Greater Noida, Uttar Pradesh
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Chandrasekar M	School of Allied Health Sciences, Galgotias university	Department of Medical Laboratory Technology, School of Allied Health Sciences, Galgotias University, Greater Noida, Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 203201 India Gautam Buddha Nagar UTTAR PRADESH	8015185002 shekarmlt09@hotmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
School Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N390\|\|Urinary tract infection, site notspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	1.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	1. Patients aged 1 year and above, of all genders 2. Patients presenting with clinical symptoms suggestive of urinary tract infection such as burning micturition, urgency, frequency, lower abdominal pain, or fever 3. Midstream clean-catch urine samples submitted for culture and antibiotic sensitivity testing 4. Urine samples showing significant bacteriuria 5. Both outpatients and inpatients from various hospital departments 6. Patients who have not received antibiotics within the previous 48 to 72 hours before urine sample collection

ExclusionCriteria

Details

1. Patients below 1 year of age
2. Urine samples that are contaminated, improperly labeled, or inadequately collected
3. Repeat or duplicate urine samples from the same patient during the same episode
4. Urine samples with polymicrobial growth (more than two organisms) unless considered under a specific sub-analysis
5. Patients with chronic urinary catheterization or known structural urinary tract abnormalities, unless studied as a separate group
6. Patients who have received antibiotic treatment within 48–72 hours prior to sample collection

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

Identification of Predominant Bacterial Pathogens

Determine the most common bacterial species isolated from urine samples (e.g., Escherichia coli, Klebsiella spp., Proteus spp., Pseudomonas aeruginosa, Enterococcus spp., etc.).

Antibiotic Sensitivity Profiles

Analyze the susceptibility patterns of the isolated organisms to commonly used antibiotics (e.g., nitrofurantoin, ciprofloxacin, ceftriaxone, amikacin, imipenem).

Determine the prevalence of multi-drug resistant (MDR) organisms.

1 year

Secondary Outcome

Outcome	TimePoints
Nil

Target Sample Size

Total Sample Size="1012"
Sample Size from India="1012"
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)

01/07/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

Spectrum of Bacterial Isolates from Urine Samples and Their Antibiotic Sensitivity Patterns

This study aims to identify the common bacterial pathogens causing urinary tract infections (UTIs) and to analyze their antibiotic sensitivity patterns. Midstream urine samples collected from patients aged 1 year and above with suspected UTIs will be cultured and tested for antimicrobial susceptibility. The research will focus on determining the prevalence of specific bacterial species and their resistance profiles to commonly prescribed antibiotics. The findings will help update local antibiogram data, support evidence-based empirical treatment, and promote rational antibiotic use, ultimately aiding in the management of UTIs and combating antimicrobial resistance in both community and hospital settings.