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Urine Collection and Novel UTI Biomarkers in Children and Older Adults

Not Yet RecruitingN/A

Sponsor: Queen's University, Belfast

Conditions: UTI - Urinary Tract Infection

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

Children:

* Children under 5 years of age who are not toilet trained.
* Urine dipstick positive for nitrates or leukocytes (including trace).
* Residual urine sample remaining following completion of all routine clinical urine testing.

Older Adults:

* Adults aged 65 years and over.
* Urine dipstick positive for nitrates or leukocytes (including trace).
* Residual urine sample remaining following completion of all routine clinical urine testing.

Exclusion Criteria:

* Consent declined.
* Inability to obtain informed consent.
* Antibiotic treatment within the previous 48 hours for acute infection.

Locations (1)

Belfast, Northern Ireland, United Kingdom