| CTRI Number |
CTRI/2025/03/081515 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to check new Inflammatory markers and their relationship with urine culture results in children with Urinary Tract Infections |
|
Scientific Title of Study
|
A clinical study to explore the role of Urinary Myeloperoxidase and Inflammatory Indexes among Paediatric patients with Urinary Tract Infection |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Garzain Bint e Attar |
| Designation |
Student |
| Affiliation |
Jamia Hamdard |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard
Mehrauli Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110062
India |
| Phone |
7006565241 |
| Fax |
|
| Email |
bgarzain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Ashif Khan |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard, Delhi |
| Address |
Department of Translational and Clinical Research, School of Chemical and Life Sciences, Jamia Hamdard
Mehrauli Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI
110062
India |
| Phone |
9891026397 |
| Fax |
|
| Email |
makhan@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neetu Shree |
| Designation |
Assistant Professor |
| Affiliation |
HAHC, Hamdard Institute of Medical Sciences and Research |
| Address |
Department of Microbiology, HIMSR and HAHC hospital
Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi
South
DELHI
110062
India |
| Phone |
9999971208 |
| Fax |
|
| Email |
drneetushree@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062 |
| Type of Sponsor |
Research institution |
|
|
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 Neetu Shree |
Hakeem Abdul Hameed Centenary Hospital |
Department of Mircobiology,Room no 5,basement HAHC Hospital -
Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, Delhi 110062
South
DELHI |
9999971208
drneetushree@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
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
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patients under 18 years of age with suspected UTIs categorized based on urine culture results, with CBC parameters collected for inflammatory index analysis |
|
| ExclusionCriteria |
| Details |
Any individual older than 18 years will be excluded from the study.
Patients with chronic medical conditions such as diabetes mellitus, chronic kidney disease, chronic liver disease, autoimmune diseases, or malignancies that may influence inflammatory markers or interfere with the accurate assessment of urinary tract infection (UTI)-related parameters.
Patients with hematologic disorders like anemia, leukemia, or any condition that could affect complete blood count (CBC) results and inflammatory indexes.
Patients with immunodeficiency disorders (e.g., HIV/AIDS or those receiving immunosuppressive therapies) that could alter immune response or inflammation levels.
Patients with a history of recent chronic infections (other than UTI) within the past 3 months that could cause systemic inflammation or affect study outcomes.
Patients with congenital or acquired urinary tract abnormalities, such as vesicoureteral reflux, obstructive uropathy, or other anatomical malformations that predispose them to recurrent infections and might skew the results.
Patients on long-term steroid therapy, immunosuppressive drugs, or anti-inflammatory medications, as these can significantly affect inflammatory markers such as AISI, SIRI, NLR, PLR, and SII.
Patients receiving antibiotic therapy for any condition other than UTI at the time of recruitment, as this could alter the bacterial load in urine culture or affect inflammatory indexes.
Patients or guardians unwilling to provide informed consent or necessary data required for the study.
Patients without a complete blood count (CBC) report or with incomplete data that prevents the calculation of the specified inflammatory indexes (AISI, SIRI, NLR, PLR, SII).
Patients who have undergone surgical interventions involving the urinary tract within the past 6 months, as this could influence UTI occurrence or inflammatory markers.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Measurement of Myeloperoxidase (MPO) levels in cases and controls.
|
Single Time Point |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the antimicrobial resistance patterns through urine culture results |
Single Time Point |
| Assessment of Inflammatory index scores through the CBC reports |
Single Time Point |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/03/2026 |
| 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="0"
Months="6"
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
|
This cross-sectional observational study explores the role of urinary myeloperoxidase (MPO) and inflammatory markers in pediatric urinary tract infections (UTIs). It aims to assess MPO as a biomarker for localized inflammation and its correlation with uropathogens and inflammatory indexes such as AISI, SIRI, NLR, PLR, and SII. The study also evaluates the relationship between inflammatory responses and different uropathogen isolates while identifying antibiotic resistance patterns. By addressing these factors, the research seeks to enhance the understanding of inflammation in pediatric UTIs and support the development of targeted treatment strategies.
|