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

Leiden University Medical Center (LUMC)

Status

Enrolling

Conditions

Urinary Tract Infection (Diagnosis)

Treatments

Diagnostic Test: Urine Biomarkers

Study type

Observational

Funder types

Other

Identifiers

nWMODIV2_2024025

Details and patient eligibility

About

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

Enrollment

264 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria