'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
Recruiting now
Conditions studied: Urinary Tract Infection (Diagnosis)
In brief
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 facts
- Study ID
- NCT06610721
- Run by
- Leiden University Medical Center
- People needed
- 264
- Starts
- 2024-08-20
- Expected to finish
- 2026-10-15
- Last updated by the study team
- 2024-09-24
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 65 years or older
- Clinically suspected UTI by treating physician
- Sufficient understanding of the Dutch language
You may not qualify if…
- Inability to obtain urine
- Inability to provide written consent
- The presence of an indwelling catheter
Where it is running
- Leiden university medical center (LUMC) — Leiden, South Holland, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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