Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06610721

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden university medical center (LUMC)

Leiden, South Holland, 2333 ZA, Netherlands

Location status: Recruiting

Location contact

Nora El Moussaoui

CONTACT

[email protected]

0031634531571

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine Biomarkers

Diagnostic Test

At baseline midstream urine will be collected in a sterile urine container.

Primary outcomes

  1. Diagnostic accuracy of individual urine biomarkers

    Time frame: At Baseline

    Sensitivity and specificity in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.

  2. Diagnostic accuracy of individual urine biomarkers

    Time frame: At Baseline

    Positive and negative predictive value in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.

  3. Diagnostic accuracy of individual urine biomarkers

    Time frame: At Baseline

    Likelihood ratios for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.

  4. Diagnostic accuracy of individual urine biomarkers

    Time frame: At Baseline

    Area under the receiver operating characteristic curve (AUC) for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.

  5. Diagnostic accuracy of urine biomarker panel

    Time frame: At Baseline

    Sensitivity and specificity in percentages for the optimal combination of biomarkers

  6. Diagnostic accuracy of urine biomarker panel

    Time frame: At Baseline

    positive and negative predictive values in percentages for the optimal combination of biomarkers.

  7. Diagnostic accuracy of urine biomarker panel

    Time frame: At Baseline

    The likelihood ratios for the optimal combination of biomarkers.

  8. Diagnostic accuracy of urine biomarker panel

    Time frame: At Baseline

    The area under the receiver operating characteristic curve (AUC) for the optimal combination of biomarkers.

  9. Diagnostic accuracy of leukocytes in urine

    Time frame: At Baseline

    Sensitivity and specificity in percentages for the cut-off of 200 leukocytes/microL in urine.

  10. Diagnostic accuracy of leukocytes in urine

    Time frame: At Baseline

    Negative and positive predictive value in percentages for the cut-off of 200 leukocytes/microL in urine

Secondary outcomes

  1. Duration of symptoms

    Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks

  2. Length of hospital stay

    Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks

  3. Complications

    Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks

  4. Recurrence of UTI <2 months

    Time frame: 8 weeks after inclusion

  5. Diagnostic performance of PA100 in detecting bacteruria

    Time frame: baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Nora El Moussaoui

CONTACT

[email protected]

0031-0634531571

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: UTI-GOLD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.