Leiden university medical center (LUMC)
Leiden, South Holland, 2333 ZA, Netherlands
Location status: Recruiting
NCT Number: NCT06610721
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
Interested in participating?
Request Info65 year and older
All sexes
Observational
Leiden, South Holland, 2333 ZA, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
At baseline midstream urine will be collected in a sterile urine container.
Time frame: At Baseline
Sensitivity and specificity in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Time frame: At Baseline
Positive and negative predictive value in percentages for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Time frame: At Baseline
Likelihood ratios for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Time frame: At Baseline
Area under the receiver operating characteristic curve (AUC) for the different biomarkers include; NGAL, IL-6, AZU, TIMP2 and CXCL9.
Time frame: At Baseline
Sensitivity and specificity in percentages for the optimal combination of biomarkers
Time frame: At Baseline
positive and negative predictive values in percentages for the optimal combination of biomarkers.
Time frame: At Baseline
The likelihood ratios for the optimal combination of biomarkers.
Time frame: At Baseline
The area under the receiver operating characteristic curve (AUC) for the optimal combination of biomarkers.
Time frame: At Baseline
Sensitivity and specificity in percentages for the cut-off of 200 leukocytes/microL in urine.
Time frame: At Baseline
Negative and positive predictive value in percentages for the cut-off of 200 leukocytes/microL in urine
Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks
Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks
Time frame: 1 week after inclusion, if not yet resolved again at 8 weeks
Time frame: 8 weeks after inclusion
Time frame: baseline
Contact information is provided by the study sponsor or research team.
Leiden University Medical Center
Other
Acronym: UTI-GOLD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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