RecruitingNCT06610721

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


Sponsor

Leiden University Medical Center

Enrollment

264 participants

Start Date

Aug 20, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria3

  • Age 65 years or older
  • Clinically suspected UTI by treating physician
  • Sufficient understanding of the Dutch language

Exclusion Criteria3

  • Inability to obtain urine
  • Inability to provide written consent
  • The presence of an indwelling catheter

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Interventions

DIAGNOSTIC_TESTUrine Biomarkers

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


Locations(1)

Leiden university medical center (LUMC)

Leiden, South Holland, Netherlands

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NCT06610721


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