'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
NCT ID: NCT06610721
Last Updated: 2024-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
264 participants
OBSERVATIONAL
2024-08-20
2026-10-15
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Elderly patients with a suspected urinary tract infection
Urine Biomarkers
At baseline midstream urine will be collected in a sterile urine container.
Interventions
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Urine Biomarkers
At baseline midstream urine will be collected in a sterile urine container.
Eligibility Criteria
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Inclusion Criteria
* Clinically suspected UTI by treating physician
* Sufficient understanding of the Dutch language
Exclusion Criteria
* Inability to provide written consent
* The presence of an indwelling catheter
65 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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Nora El Moussaoui
drs. N. El Moussaoui
Locations
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Leiden university medical center (LUMC)
Leiden, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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El Moussaoui N, van Andel E, van der Beek MT, Vlot JA, Bilsen MP, van Nieuwkoop C, Lauw FN, Delfos NM, Stalenhoef JE, Sijbom M, Akintola AA, Achterberg WP, Goeman JJ, Leyten EMS, van Uhm JIM, Corstjens PLAM, Mooijaart SP, Conroy SP, Cobbaert CM, Visser LG, Lambregts MMC. 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. BMJ Open. 2025 Jun 18;15(6):e103311. doi: 10.1136/bmjopen-2025-103311.
Other Identifiers
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nWMODIV2_2024025
Identifier Type: -
Identifier Source: org_study_id
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