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CTRI Number  CTRI/2025/11/097348 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 12/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study on Bacterial Factors Causing Urinary Tract Infections and Recurrence in Elderly Women 
Scientific Title of Study   Exploring Pathogen Factors Contributing to Urinary Tract Infections and Recurrence in Peri and Postmenopausal Women 
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 Vandana K E 
Designation  Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Department oF Microbiology, Kasturba Medical College, Manipal, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9902206009  
Fax    
Email  vandana.ke@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Ancita lobo 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Department oF Microbiology, Kasturba Medical College, Manipal, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9449953453  
Fax    
Email  ancita.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ancita lobo 
Designation  PhD Scholar 
Affiliation  Kasturba Medical College, Manipal 
Address  Department oF Microbiology, Kasturba Medical College, Manipal, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9449953453  
Fax    
Email  ancita.kmcmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  ICMR 
Address  Indian Council of Medical Research, New Delhi, 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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 Vandana K E  Kasturba Hospital  Department of Microbiology, Nephrology, General Medicine, Obstetrics and Gynaecology, and Infectious Diseases, Kasturba Hospital, Manipal, 576104- Udupi, Karnataka, India
Udupi
KARNATAKA 
09449953453

ancita.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N309||Cystitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  45 to 65-year-old female with two or more urinary tract infection symptoms, admitted in units- MED, OBG, IFD, NPH of Kasturba Hospital, Manipal. 
 
ExclusionCriteria 
Details  Women with major systemic illnesses, indwelling catheters, recent urogenital surgery, or recent antibiotic use will be excluded to avoid confounding factors. Those with anatomical abnormalities such as prolapse, vaginal atrophy, neurogenic bladder, or significant urinary obstruction will also be excluded. Participants unable to provide consent will not be included. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will determine the regional prevalence and recurrence patterns of UTIs in peri and postmenopausal women, propose an improved pyuria threshold to enhance diagnostic accuracy, identify bacterial persistence, and characterize the baseline urinary microbiome associated with infection in this population.  Samples and data will be collected at the time of initial admission, during the hospital stay, and again only if the participant is re admitted with UTI within the 24 month study period. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
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)   01/12/2025 
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="2"
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  

Urinary tract infections are among the most common infections in women, with increased incidence and recurrence observed in peri and postmenopausal age groups. This study aims to explore bacterial factors that contribute to the onset and recurrence of UTIs in women aged 45 to 65 years. The focus is on understanding the clinical, microbiological, and molecular characteristics of uropathogens, particularly uropathogenic Escherichia coli. The study includes clinical analysis of urine samples for standard parameters and correlation of findings with patient symptoms. Isolated UPEC strains will undergo molecular typing using ERIC PCR to determine clonal patterns, and selected recurrent isolates will be further analyzed by whole genome sequencing to identify resistance genes, virulence factors, and persistence traits. In addition, the study will investigate the presence of persisters among UPEC strains and test the efficacy of antibiotics and potential anti persister agents using time kill assays. To capture the broader microbial landscape, fresh catheter urine samples will be subjected to shotgun metagenomic sequencing to identify uncultured and fastidious organisms that may contribute to infection. This multidisciplinary approach integrates clinical data, molecular microbiology, and metagenomics to improve the understanding of pathogen behavior in UTIs and recurrent infections. The findings are expected to inform more accurate diagnostics, appropriate pyuria cutoff values, and therapeutic strategies in managing UTIs among elderly women.


 
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