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'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
Sponsor: Leiden University Medical Center
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
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
OBSERVATIONAL
Enrollment
264
Start Date
2024-08-20
Completion Date
2026-10-15
Last Updated
2024-09-24
Healthy Volunteers
No
Conditions
Interventions
Urine Biomarkers
At baseline midstream urine will be collected in a sterile urine container.
Locations (1)
Leiden university medical center (LUMC)
Leiden, South Holland, Netherlands