NCT06610721

'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 264 (estimated)
• Sponsor: Leiden University Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to improve the diagnosis of urinary tract infections (UTI) in older people (≥65 years). The main research questions are: Research questions * What is the optimal cut-off for each individual biomarker NGAL,IL-6,AZU,TIMP2 and CXCL9 and associated, sensitivity, specificity, negative and positive predictive value. * sensitivity, specificity, negative and positive predictive value of a urine leukocyte count cut-off of 200 cells/microL (validation) * What is the optimal combination of biomarkers for UTI diagnosis in older patients * As a secondary objective this study aims to evaluate the association between the levels of individual biomarker levels and 1) duration of symptoms 2) complications, 3) recurrence of UTI within 2 months, and length of hospital stay. Next to this, the performance of the astrego PA100 will be validated in diagnosing bacteriuria. Participants will: * be asked to provide a urine sample once at the beginning of the study * be asked to answer some questions about their symptoms and overall health at the beginning of the study and after 8 weeks * have their vital parameters (temperature and blood pressure) measured once at the beginning of the study

Conditions

• Urinary Tract Infection (Diagnosis)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urine Biomarkers	At baseline midstream urine will be collected in a sterile urine container.

Timeline

• Start date: 2024-08-20
• Primary completion: 2026-08-20
• Completion: 2026-10-15
• First posted: 2024-09-24
• Last updated: 2024-09-24

Locations

1 site across 1 country: Netherlands