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Recruiting
NCT05726318
Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women
Conditions: UTI
Sex: Female
Ages: 65 Years – N/A
Phase: PHASE4
Enrollment: 70
Sponsor: Megan Bradley
Location: United States
Summary
To evaluate the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported UTI symptoms in older women and the adherence to study procedures.
Eligibility Criteria
Inclusion Criteria:Female biologic SexAge ≥65 years oldHistory of recurrent UTI per patient report of greater than 2 UTIs in the last 6 months or 3 UTIs in the last yearPatient reported UTI defined as:Dysuria, increased urinary urgency/frequency and/or suprapubic painExclusion Criteria:Male biologic sexAge <65 years oldHistory of augmentation cystoplasty or cystectomyCurrently performing clean intermittent self-catheterizationCurrent indwelling foley catheterUrinary tract instrumentation (i.e., cystourethroscopy, foley catheter placement) in the last 30 daysUndergoing treatment for malignancyHistory of either confirmed or patient reported pyelonephritis and/or urosepsisCirrhosis and/or end stage liver diseaseChronic kidney disease with most recent estimated glomerular filtration rate <50 ml/minDementia and/or currently reside in skilled nursing facilityCurrent high-dose chronic steroids (>20mg/day of prednisone)Previous solid organ transplantProvider concern for pyelonephritis and/or sepsis (i.e., fevers)Unwilling or unable to comply with study procedures
Source: ClinicalTrials.gov (NCT05726318). StuddyBuddy aggregates publicly available trial information.