NCT06610721 'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
| NCT ID | NCT06610721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Urinary Tract Infection (Diagnosis) |
| Study Type | OBSERVATIONAL |
| Enrollment | 264 participants |
| Start Date | 2024-08-20 |
| Primary Completion | 2026-08-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 264 participants in total. It began in 2024-08-20 with a primary completion date of 2026-08-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
Inclusion criteria: * Age 65 years or older * Clinically suspected UTI by treating physician * Sufficient understanding of the Dutch language Exclusion criteria: * Inability to obtain urine * Inability to provide written consent * The presence of an indwelling catheter
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06610721 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Urinary Tract Infection (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06610721 currently recruiting?
Yes, NCT06610721 is actively recruiting participants. Contact the research team at n.el_moussaoui@lumc.nl for enrollment information.
Where is the NCT06610721 trial being conducted?
This trial is being conducted at Leiden, Netherlands.
Who is sponsoring the NCT06610721 clinical trial?
NCT06610721 is sponsored by Leiden University Medical Center. The trial plans to enroll 264 participants.