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

September 23, 2024 updated by: Nora El Moussaoui, Leiden University Medical Center

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Zuid-Holland
      • Leiden, Zuid-Holland, Netherlands, 2333 ZA
        • Recruiting
        • Leiden University Medical Center (LUMC)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited in the hospital setting, long term care and general practice. Patients will be recruited through an existing network of hospitals, primary care offices and long stay facilities in the Leiden and the Hague region (the Netherlands). Additionally, there is a collaboration with university college hospital in London (the UK).

Patients with suspected UTI in these centers will be identified by their attending healthcare provider. The attending healthcare provider will notify the study team, who will proceed the inclusion process.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly patients with a suspected urinary tract infection
Diagnostic test: Urine Biomarkers
At baseline midstream urine will be collected in a sterile urine container.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At Baseline
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.
At Baseline
Diagnostic accuracy of individual urine biomarkers
Time Frame: At Baseline
Likelihood ratios for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
At Baseline
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.
At Baseline
Diagnostic accuracy of urine biomarker panel
Time Frame: At Baseline
Sensitivity and specificity in percentages for the optimal combination of biomarkers
At Baseline
Diagnostic accuracy of urine biomarker panel
Time Frame: At Baseline
positive and negative predictive values in percentages for the optimal combination of biomarkers.
At Baseline
Diagnostic accuracy of urine biomarker panel
Time Frame: At Baseline
The likelihood ratios for the optimal combination of biomarkers.
At Baseline
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.
At Baseline
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.
At Baseline
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
At Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of symptoms
Time Frame: 1 week after inclusion, if not yet resolved again at 8 weeks
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
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
1 week after inclusion, if not yet resolved again at 8 weeks
Recurrence of UTI <2 months
Time Frame: 8 weeks after inclusion
8 weeks after inclusion
Diagnostic performance of PA100 in detecting bacteruria
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2024

Primary Completion (Estimated)

August 20, 2026

Study Completion (Estimated)

October 15, 2026

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nWMODIV2_2024025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

data will be shared in a registry. after completion of the study. The data sharing plan will be developed

IPD Sharing Time Frame

to be determined

IPD Sharing Access Criteria

to be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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