Actively Recruiting

Age: 65Years +
All Genders
NCT06610721

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

Led by Leiden University Medical Center · Updated on 2024-09-24

264

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older
  • Clinically suspected UTI by treating physician
  • Sufficient understanding of the Dutch language
Not Eligible

You will not qualify if you...

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

AI-Screening

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Trial Site Locations

Total: 1 location

1

Leiden university medical center (LUMC)

Leiden, South Holland, Netherlands, 2333 ZA

Actively Recruiting

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Research Team

N

Nora El Moussaoui

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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