| CTRI Number |
CTRI/2025/10/095759 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinicoetiological Profile and Risk Factors Of Urinary Tract Infections in Children |
|
Scientific Title of Study
|
Clinicoetiological Profile and Risk Factors Of Urinary Tract Infections in Children aged 1 Month to 18 Years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AISHWARYA PRASHANTH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
DEPARTMENT OF PEDIATRICS ,KASTURBA MEDICAL COLLEGE ,MAHE ,MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
7022618900 |
| Fax |
|
| Email |
aishwarya.5.prashanth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAREN JANICE MORAS |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
DEPARTMENT OF PEDIATRICS ,KASTURBA MEDICAL COLLEGE ,MAHE ,MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
7022618900 |
| Fax |
|
| Email |
karen.moras@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
AISHWARYA PRASHANTH |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE MANIPAL |
| Address |
Department of Pediatrics ,Kasturba Medical College ,MAHE ,Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7022618900 |
| Fax |
|
| Email |
aishwarya.5.prashanth@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AISHWARYA PRASHANTH |
| Address |
DEPARTMENT OF PEDIATRICS ,KASTURBA MEDICAL COLLEGE, MAHE, MANIPAL-576104 |
| Type of Sponsor |
Other [no sponsor needed as it is a part of standard of care] |
|
|
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 AISHWARYA PRASHANTH |
KASTURBA HOSPITAL MANIPAL |
Department of Pediatrics
Udupi
KARNATAKA |
7022618900
aishwarya.5.prashanth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital - Student Research |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 1 month to 18 years having symptoms of urinary tract infection including 1st episode
and recurrent UTI admitted in Paediatrics department
Culture positive UTI
Culture negative UTI Positive urine routine pyuria with leukocyte positive or nitrite positive |
|
| ExclusionCriteria |
| Details |
Urine culture showing polymicrobial growth
Catheter associated UTI
Asymptomatic culture negative UTI with sterile pyuria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To perform Urine culture and sensitivity
Urine routine ,CBC, ESR, CRP, RFT (radiological imaging if indicated) |
At admission all investigations will be done and at 3 months follow up (at follow up urine routine and urine culture sensitivity will be done). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
22/10/2025 |
| 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="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A prospective study- cross sectional study titled - Clinicoetiological Profile and Risk Factors Of Urinary Tract Infections in Children aged 1 Month to 18 Years will be conducted for a study period of 18 months to study the clinicoetiological profile of urinary tract infection in children and identify the risk factors for UTI in children. Once CTRI registration is complete and inclusion and exclusion criteria are met the participants admitted in pediatrics ward will be selected after taking an informed consent .Detailed history and clinical examination will be done .Urine and blood samples will be collected under aseptic precautions and investigations such as CBC,ESR,CRP,RFT urine routine, urine culture and sensitivity will be performed .Radiological imaging will be performed as per standard of care protocol .The data will be analyzed using appropriate statistic techniques .A 3 month follow up will be done to asses any complications related to UTI or look for recurrence during which urine routine and urine culture and sensitivity will be performed .
|