About this trial
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
This trial does not accept healthy volunteersQualifiers
Age 65 years or older
Clinically suspected UTI by treating physician
Sufficient understanding of the Dutch language
Disqualifiers
Inability to obtain urine
Inability to provide written consent
The presence of an indwelling catheter
Trial 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.
Trial design
Other
Prospective
Treatments tested in this trial
Urine Biomarkers
Diagnostic testAt baseline midstream urine will be collected in a sterile urine container.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy of individual urine biomarkers
Sensitivity and specificity in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
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.
Diagnostic accuracy of individual urine biomarkers
Likelihood ratios for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
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.
Secondary outcomes
Duration of symptoms
Length of hospital stay
Complications
Recurrence of UTI <2 months
Sponsors and contacts
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