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

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

Recruiting
65 years and older
All
Phase N/A

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Overview

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

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

Study details
    Urinary Tract Infection (Diagnosis)

NCT06610721

Leiden University Medical Center

15 October 2025

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