Clinical trial NCT06610721: 'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
Official title: 'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urinary Tract Infection (Diagnosis)
Keywords: Urinary tract infection
Biomarkers
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 264
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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


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

Primary outcomes:
measure: Diagnostic accuracy of individual urine biomarkers
timeFrame: At Baseline
measure: Diagnostic accuracy of individual urine biomarkers
timeFrame: At Baseline
measure: Diagnostic accuracy of individual urine biomarkers
timeFrame: At Baseline
measure: Diagnostic accuracy of individual urine biomarkers
timeFrame: At Baseline
measure: Diagnostic accuracy of urine biomarker panel
timeFrame: At Baseline
measure: Diagnostic accuracy of urine biomarker panel
timeFrame: At Baseline
measure: Diagnostic accuracy of urine biomarker panel
timeFrame: At Baseline
measure: Diagnostic accuracy of urine biomarker panel
timeFrame: At Baseline
measure: Diagnostic accuracy of leukocytes in urine
timeFrame: At Baseline
measure: Diagnostic accuracy of leukocytes in urine
timeFrame: At Baseline
Secondary outcomes:
measure: Duration of symptoms
timeFrame: 1 week after inclusion, if not yet resolved again at 8 weeks
measure: Length of hospital stay
timeFrame: 1 week after inclusion, if not yet resolved again at 8 weeks
measure: Complications
timeFrame: 1 week after inclusion, if not yet resolved again at 8 weeks
measure: Recurrence of UTI &lt;2 months
timeFrame: 8 weeks after inclusion
measure: Diagnostic performance of PA100 in detecting bacteruria
timeFrame: baseline
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden university medical center (LUMC)
state: Zuid-Holland
Study officials:
References: