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'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'

NCT06610721 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 264

Last updated 2024-09-24

No results posted yet for this study

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

Conditions

  • Urinary Tract Infection (Diagnosis)

Interventions

DIAGNOSTIC_TEST

Urine Biomarkers

At baseline midstream urine will be collected in a sterile urine container.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-20
Primary Completion
2026-08-20
Completion
2026-10-15

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06610721 on ClinicalTrials.gov