Actively Recruiting
Led by Leiden University Medical Center · Updated on 2024-09-24
264
Participants Needed
1
Research Sites
8 weeks
Total Duration
This research aims to improve the diagnosis of urinary tract infections (UTI) in older adults aged 65 years and above. It focuses on finding the best cut-off values for individual urine biomarkers such as NGAL, IL-6, AZU, TIMP2, and CXCL9, along with assessing the sensitivity, specificity, and predictive values of these markers. The study also seeks to validate urine leukocyte count cut-offs and evaluate the combination of biomarkers for better diagnosis. Additionally, it will explore how biomarker levels relate to symptom duration, complications, recurrence within two months, and hospital stay length. The performance of the astrego PA100 device in detecting bacteriuria will also be validated. Participants will provide a midstream urine sample once at the start of the study, which will be collected in a sterile container for biomarker testing. They will answer questions about their symptoms and general health at the beginning and again after eight weeks. Vital signs, including temperature and blood pressure, will be measured once at the start. This observational study does not involve any treatment but focuses on diagnostic assessments. During the study, participants will be monitored for symptoms and potential complications. Researchers will track symptom duration, hospital stay lengths, and recurrence of UTI over an eight-week period. Diagnostic accuracy of individual biomarkers and their combinations will be evaluated at baseline. The study will also assess the diagnostic performance of the PA100 device for bacteriuria detection. Overall participation involves two assessments and one urine sample collection, spanning about eight weeks from inclusion to follow-up.
CONDITIONS
'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants provide a baseline urine sample for biomarker testing to assist in diagnosing urinary tract infections.
1 visit (in-person)
Duration - Up to 8 weeks
Participants are monitored for symptom duration, hospital stay length, complications, and recurrence of infection up to 8 weeks after inclusion.
Follow-up visits at 1 week and 8 weeks after inclusion
Total: 1 location
1
Leiden university medical center (LUMC)
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
N
Nora El Moussaoui
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Nora El Moussaoui, Esther van Andel, Martha T van der Beek...
https://pubmed.ncbi.nlm.nih.gov/40533212