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NCT06610721: UTI-GOLD
'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
trial testing Urine Biomarkers in Urinary Tract Infection (Diagnosis) in 264 participants. Currently enrolling.
20 August 2026
Quick facts
| Lead sponsor | Leiden University Medical Center |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 264 |
| Start date | 20 August 2024 |
| Primary completion | 20 August 2026 |
| Estimated completion | 15 October 2026 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Urine Biomarkers
Conditions studied
- Urinary Tract Infection (Diagnosis) — all drugs for Urinary Tract Infection (Diagnosis) →
Sponsor
Leiden University Medical Center
Who can join
65 and older, any sex, with Urinary Tract Infection (Diagnosis). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Validation of urinary biomarkers for accurate diagnosis of urinary tract infections in older adults across primary care, hospitals and long-term care facilities in the Netherlands and UK (UTI-GOLD): a multicentre observational study protocol.
El Moussaoui N, van Andel E, van der Beek MT, Vlot JA, et al · · 2025 · cited 3× · PMID 40533212 · DOI 10.1136/bmjopen-2025-103311
Verify or expand the search:
- PubMed search for NCT06610721
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Urinary Tract Infection (Diagnosis)
Currently open trials in the same condition.
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- NCT06896643 — Urinary Infection and Colonization in Bone Procedures · recruiting
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- NCT06962644 — Association of Urinary Tract Infection With Preeclampsia During Pregnancy · recruiting
Other Leiden University Medical Center trials
Trials by the same sponsor.
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- NCT07498738 — Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions · NA · not yet recruiting
- NCT06545292 — Microsampling for Therapeutic Drug Monitoring of Oral Oncolytics in Oncology Patients · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06610721 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Leiden University Medical Center
- Last refreshed: 24 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06610721.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing