Urinary Tract Infection (Diagnosis)
Conditions
Keywords
Urinary tract infection, Biomarkers
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
Interventions
DIAGNOSTIC_TESTUrine Biomarkers
At baseline midstream urine will be collected in a sterile urine container.
Sponsors
Leiden University Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of individual urine biomarkers | At Baseline | Sensitivity and specificity in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9. |
| Diagnostic accuracy of urine biomarker panel | At Baseline | Sensitivity and specificity in percentages for the optimal combination of biomarkers |
| Diagnostic accuracy of leukocytes in urine | At Baseline | Sensitivity and specificity in percentages for the cut-off of 200 leukocytes/microL in urine. |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence of UTI <2 months | 8 weeks after inclusion |
| Duration of symptoms | 1 week after inclusion, if not yet resolved again at 8 weeks |
| Diagnostic performance of PA100 in detecting bacteruria | baseline |
| 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 |
Countries
Netherlands
Contacts
Primary ContactNora El Moussaoui
Outcome results
None listed