| 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
|
|
|
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
|
|
|
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. |