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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorLeiden University Medical Center

About this trial

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 criteria

Qualifiers

Age 65 years or older

Clinically suspected UTI by treating physician

Sufficient understanding of the Dutch language

Disqualifiers

Inability to obtain urine

Inability to provide written consent

The presence of an indwelling catheter

Trial design

Treatments tested in this trial

  • Urine Biomarkers

Treatment groups

264 Participants
are divided into 1 treatment group