'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
- Conditions
- Urinary Tract Infection (Diagnosis)
- Interventions
- Diagnostic Test: Urine Biomarkers
- Registration Number
- NCT06610721
- Lead Sponsor
- Leiden University Medical Center
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 264
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Elderly patients with a suspected urinary tract infection Urine Biomarkers -
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of individual urine biomarkers At Baseline Area under the receiver operating characteristic curve (AUC) for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Diagnostic accuracy of urine biomarker panel At Baseline The area under the receiver operating characteristic curve (AUC) for the optimal combination of biomarkers.
Diagnostic accuracy of leukocytes in urine At Baseline Negative and positive predictive value in percentages for the cut-off of 200 leukocytes/microL in urine
- Secondary Outcome Measures
Name Time Method Duration of symptoms 1 week after inclusion, if not yet resolved again at 8 weeks Length of hospital stay 1 week after inclusion, if not yet resolved again at 8 weeks Complications 1 week after inclusion, if not yet resolved again at 8 weeks Recurrence of UTI <2 months 8 weeks after inclusion Diagnostic performance of PA100 in detecting bacteruria baseline
Trial Locations
- Locations (1)
Leiden university medical center (LUMC)
🇳🇱Leiden, Zuid-Holland, Netherlands