| CTRI Number |
CTRI/2025/03/082079 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors that contribute to worse health outcomes in patients with fever-related urinary tract infections (UTIs) acquired outside the hospital, treated at a major hospital in South India. |
|
Scientific Title of Study
|
Risk Factors for poor clinical outcomes in Adults with febrile community acquired urinary tract infections in a Tertiary care hospital in South India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Medha Menon |
| Designation |
Junior Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of General Medicine, 2nd Floor, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, India, PINCODE-576104
Udupi
KARNATAKA
576104
India |
| Phone |
7327003567 |
| Fax |
|
| Email |
drmedhamenon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandrashekar UK |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of General Medicine, 2nd Floor, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, India, PINCODE-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845163448 |
| Fax |
|
| Email |
shekar.uk@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chandrashekar UK |
| Designation |
Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of General Medicine, 2nd Floor, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, India, PINCODE-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845163448 |
| Fax |
|
| Email |
shekar.uk@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, PINCODE- 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Medha Menon |
| Address |
Department of General Medicine, 2nd floor, Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, PINCODE 576104 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Medha Menon |
Kasturba Hospital |
Department of General Medicine, Depart of Infectious Diseases, Kasturba Hospital, Manipal, Karnataka, PINCODE 576104
Udupi
KARNATAKA |
7327003567
drmedhamenon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 |
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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18 and older of either gender
2. In the in-patient dept of General Medicine and Infectious diseases
3. With urinary symptoms of suprapubic tenderness, costovertebral angle tenderness, dysuria, frequency, urgency and fever in first 24 hours of admission |
|
| ExclusionCriteria |
| Details |
1. Urinary catheter in in situ for more than 24 hours at time of admission
2. UTI presumed to be acquired in the hospital
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Frequency of clinical failure at Day 14 after start of treatment in febrile community acquired UTI |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of microbiological failure at Day 14 after start of treatment in febrile community acquired UTI |
14 days |
To know the microbial spectrum and antimicrobial susceptibility pattern in febrile UTI
|
14 days |
To determine appropriateness of empirical antibiotic prescription
|
14 days |
|
|
Target Sample Size
|
Total Sample Size="211"
Sample Size from India="211"
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)
|
15/03/2025 |
| 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 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
|
This is a prospective longitudinal study to identify the risk factors associated with poor clinical outcomes in febrile community acquired UTI. 211 participants will be included in the study The primary objective is to identify the frequency of clinical failure at day 14 after starting treatment and secondary objectives are to identify the frequency of microbiological failure at Day 14 after start of treatment in febrile community acquired UTI, to know the microbial spectrum and antimicrobial susceptibility pattern in febrile UTI and to determine appropriateness of empirical antibiotic prescription. |