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Recruiting NCT06610721

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

— Observational Urinary Tract Infection (Diagnosis)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Urine Biomarkers.
Who it may be relevant to
Registry conditions: Urinary Tract Infection (Diagnosis). Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Diagnostic test Urine Biomarkers
    At baseline midstream urine will be collected in a sterile urine container.

Primary outcome measures

  • Diagnostic accuracy of individual urine biomarkers [Time frame: At Baseline]
  • Diagnostic accuracy of individual urine biomarkers [Time frame: At Baseline]
  • Diagnostic accuracy of individual urine biomarkers [Time frame: At Baseline]
  • Diagnostic accuracy of individual urine biomarkers [Time frame: At Baseline]
  • Diagnostic accuracy of urine biomarker panel [Time frame: At Baseline]
  • Diagnostic accuracy of urine biomarker panel [Time frame: At Baseline]
  • Diagnostic accuracy of urine biomarker panel [Time frame: At Baseline]
  • Diagnostic accuracy of urine biomarker panel [Time frame: At Baseline]
  • Diagnostic accuracy of leukocytes in urine [Time frame: At Baseline]
  • Diagnostic accuracy of leukocytes in urine [Time frame: At Baseline]
Secondary outcome measures (5)
  • Duration of symptoms [Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks]
  • Length of hospital stay [Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks]
  • Complications [Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks]
  • Recurrence of UTI <2 months [Time frame: 8 weeks after inclusion]
  • Diagnostic performance of PA100 in detecting bacteruria [Time frame: baseline]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Netherlands · 1 center
  • Leiden university medical center (LUMC) — Leiden

Publications

  • El Moussaoui N, van Andel E, van der Beek MT, Vlot JA, Bilsen MP, van Nieuwkoop C, Lauw FN, Delfos NM, Stalenhoef JE, Sijbom M, Akintola AA, Achterberg WP, Goeman JJ, Leyten EMS, van Uhm JIM, Corstjens PLAM, Mooijaart SP, Conroy SP, Cobbaert CM, Visser LG, Lambregts MMC. Validation of urinary biomarkers for accurate diagnosis of urinary tract infections in older adults across primary care, hospita PMID 40533212

Identifiers

NCT: NCT06610721 · nWMODIV2_2024025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗