Urine COLLECTion technique and novel UTI biomarkers in children v1.0
Research type
Research Study
Full title
Evaluating novel biomarkers and the effect of urine collection technique in young children with urinary tract infection
IRAS ID
352075
Contact name
Tom Waterfield
Contact email
Sponsor organisation
Queen's University Belfast
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Urinary tract infections (UTIs) are a common bacterial infection in young children, and early diagnosis is important. Obtaining uncontaminated urine samples is an issue when investigating UTIs in children who have not been toilet trained, and current UTI urine tests in this age group are prone to false positive results. The diagnostic uncertainly around UTI testing in children leads to over use of antibiotics. Novel immune system biomarkers and bacterial gene expression markers may provide a more specific means of diagnosing UTIs than conventional tests. The aim of this study is to determine the effect of urine sample collection on novel UTI biomarker accuracy and whether assessing urine bacterial gene expression can differentiate contamination from infection.
COLLECT-UTI will collect residual urine samples from 180 children less than 5 years old with suspected UTI in the children's hospital emergency department at the Royal Victoria Hospital, Belfast. Residual urine samples leftover from routine UTI testing will be stored for research use. Residual blood will also be collected, if taken during routine phlebotomy and stored for additional analysis. All children will get emergency clinical care as usual without delays. Because the management of possible UTI is time critical, we will use a method of delayed consent from the parents/guardians which is nationally accepted. Samples will be stored for research within the emergency department until it is appropriate to obtain consent. Optional perianal swabs will also be offered after consent to compare bacteria from swabs and urine. Symptoms, clinical features, treatment and laboratory results will be recorded on an electronic case report form (CRF). The urine samples will be used to check how accurate the novel biomarkers are at detecting UTI. Parents will also be given the option to consent to being contacted in the future to be invited to patient and public involvement.
REC name
HSC REC B
REC reference
25/NI/0077
Date of REC Opinion
10 Jun 2025
REC opinion
Favourable Opinion