An observational study in UTI - Urinary Tract Infection, sponsored by Queen's University, Belfast. Recruiting at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Queen's University, Belfast · Observational
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.
Background:
Urinary tract infection (UTI) is one of the most common bacterial infections requiring medical assessment in young children and older adults. Accurate diagnosis is particularly challenging at the extremes of age, where patients frequently present with non-specific symptoms and current urine diagnostic tests perform poorly. In young children, contamination of urine samples collected using non-invasive methods often results in false-positive urine cultures, while in older adults the high prevalence of asymptomatic bacteriuria (ASB) makes it difficult to distinguish bacterial colonisation from true infection. These diagnostic limitations contribute to unnecessary antibiotic prescribing, avoidable hospital admissions and increased antimicrobial resistance. This study aims to evaluate novel urinary host and bacterial biomarkers to improve the diagnosis of UTI by distinguishing true infection from contamination in children and from ASB in older adults.
Objectives:
Primary Objectives:
Study Design:
A prospective observational study conducted in the Emergency Departments of the Royal Belfast Hospital for Sick Children and the Royal Victoria Hospital. The paediatric component comprises a diagnostic accuracy cohort study with a nested case-control transcriptomic study, while the adult component is a case-control study comparing symptomatic UTI with asymptomatic bacteriuria.
Study Population:
Children under 5 years of age who are not toilet trained and have urine sent for culture for suspected UTI, and adults aged 65 years and over undergoing urine culture for suspected UTI in the Emergency Department. Participants must have sufficient residual urine remaining following routine clinical testing. Exclusion criteria include inability to obtain consent and antibiotic treatment within the preceding 48 hours.
Setting:
Royal Belfast Hospital for Sick Children Emergency Department and Royal Victoria Hospital Emergency Department, Belfast.
Screening:
Potential participants will be identified by the clinical care team. Following informed consent, clinical information and laboratory results will be recorded on a case report form (CRF), with clinical outcomes reviewed 14 days after presentation.
Procedures:
Residual urine samples collected during routine clinical care will be retained following consent. Where available, residual plasma from routine blood sampling may also be stored. No additional urine collection or phlebotomy will be performed for research purposes. Samples will be pseudonymised, transported to Queen's University Belfast for storage and analysis, and used for urinary biomarker measurement, bacterial RNA sequencing and bacterial isolate banking.
Reference Standards:
In children, UTI will be defined using predefined urine culture thresholds according to urine collection method. Samples selected for bacterial RNA sequencing may include urine from children with confirmed UTI, contaminated urine samples and, where available, healthy control samples. In older adults, symptomatic UTI and asymptomatic bacteriuria will be classified using documented urinary symptoms together with urine culture results according to established guideline criteria.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's planned enrollment of 230 is close to the median of 236 across 198 observational studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children:
Older Adults:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days from attendance
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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