Urine Collection and Novel UTI Biomarkers in Children and Older Adults

NCT07766278 | Not Yet Recruiting

• 1 other identifier: NIB26-0004
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Urinary Tract Infection; Paediatrics; Older Adults; Biomarkers; Urine

Outcome Measures

Primary Outcomes (3)

• Sensitivity, specificity and area under the receiver operating characteristic curve (AUC) of urinary host biomarkers for paediatric UTI

  The diagnostic performance of urinary host biomarkers for paediatric UTI will be evaluated against the reference standard urine culture. Sensitivity, specificity and area under the receiver operating characteristic curve (AUC) will be calculated, with diagnostic performance also compared across urine collection methods.

  14 days from attendance

• Molecular characterisation of paediatric urine samples

  Molecular analyses will be performed to identify biological signatures associated with different urine sample classifications, including confirmed UTI, contaminated samples and, where available, healthy controls.

  14 days from attendance

• Molecular characterisation of urine samples from older adults

  Molecular analyses will be performed to identify biological signatures associated with symptomatic UTI and asymptomatic bacteriuria.

  14 days from attendance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children under 5 years olds and older adults aged 65 years and over, attending the Royal Victoria Hospital Emergency Departments who are undergoing routine clinical investigation for suspected urinary tract infection.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Sites (1)

Queen's University Belfast

Belfast, Northern Ireland, BT9 7BL, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 17, 2026
• Primary Completion (Estimated): August 17, 2028
• Study Completion (Estimated): August 17, 2029
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

GB (1)