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

NCT06610721 | Recruiting

• 1 other identifier: nWMODIV2_2024025
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Urinary Tract Infection (Diagnosis)

Keywords

Urinary tract infection; Biomarkers

Outcome Measures

Primary Outcomes (10)

• Diagnostic accuracy of individual urine biomarkers

  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

  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

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

  At Baseline

• Diagnostic accuracy of individual urine biomarkers

  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

  Sensitivity and specificity in percentages for the optimal combination of biomarkers

  At Baseline

• Diagnostic accuracy of urine biomarker panel

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

  At Baseline

• Diagnostic accuracy of urine biomarker panel

  The likelihood ratios for the optimal combination of biomarkers.

  At Baseline

• Diagnostic accuracy of urine biomarker panel

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

  At Baseline

• Diagnostic accuracy of leukocytes in urine

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

  At Baseline

• Diagnostic accuracy of leukocytes in urine

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

  At Baseline

Secondary Outcomes (5)

• Duration of symptoms

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

• Length of hospital stay

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

• Complications

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

• Recurrence of UTI <2 months

  8 weeks after inclusion

• Diagnostic performance of PA100 in detecting bacteruria

  baseline

Study Arms (1)

Elderly patients with a suspected urinary tract infection

Diagnostic Test: Urine Biomarkers

Interventions

Urine Biomarkers DIAGNOSTIC_TEST

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

Elderly patients with a suspected urinary tract infection

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden university medical center (LUMC)

Leiden, South Holland, 2333 ZA, Netherlands

RECRUITING

Related Publications (1)

• 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, hospitals and long-term care facilities in the Netherlands and UK (UTI-GOLD): a multicentre observational study protocol. BMJ Open. 2025 Jun 18;15(6):e103311. doi: 10.1136/bmjopen-2025-103311.

  PMID: 40533212 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Urine

MeSH Terms

Conditions

Urinary Tract Infections; Disease

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nora El Moussaoui

CONTACT

0031-0634531571; n.el_moussaoui@lumc.nl

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: drs. N. El Moussaoui

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 24, 2024
• Study Start: August 20, 2024
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: to be determined
• Access Criteria: to be determined

Locations

NL (1)