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Urine Collection and Novel UTI Biomarkers in Children and Older Adults

NCT07766278 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2026-08-14

No results posted yet for this study

Summary

Suspected urinary tract infection (UTI) is a common driver of antibiotic prescribing and hospital admission, yet accurate diagnosis remains challenging. Young children and older adults often present without localising urinary symptoms, and current urine tests perform poorly in these groups. In non-toilet-trained children, non-invasive urine collection methods are associated with high contamination rates. In older adults, asymptomatic bacteriuria (ASB) is common and complicates interpretation of urine culture results. As UTIs are a leading cause of sepsis in both groups, this diagnostic uncertainty contributes to overdiagnosis and overtreatment. COLLECT-UTI aims to improve UTI diagnostics by evaluating novel urinary host and bacterial markers to distinguish true UTI from contaminated samples in children and from ASB in older adults.

The COLLECT-UTI study is a prospective observational study of children under 5 years of age and adults aged 65 years and over undergoing testing for suspected urinary tract infection (UTI). The study will recruit approximately 230 participants in total. Clinical features, laboratory results and 14-day outcomes will be recorded on an electronic case report form (CRF) and REDCap database. Residual urine samples collected during routine clinical care will be used to investigate novel urinary host biomarkers and bacterial markers to improve the diagnosis of UTI.

Conditions

  • UTI - Urinary Tract Infection

Sponsors & Collaborators

  • Queen's University, Belfast

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2028-08-17
Completion
2029-08-17

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766278 on ClinicalTrials.gov