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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Age 65 years or older

• Clinically suspected UTI by treating physician

• Sufficient understanding of the Dutch language

Locations
Other Locations
Netherlands
Leiden university medical center (LUMC)
RECRUITING
Leiden
Contact Information
Primary
Nora El Moussaoui
n.el_moussaoui@lumc.nl
0031-0634531571
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2026-10-15
Participants
Target number of participants: 264
Treatments
Elderly patients with a suspected urinary tract infection
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov