Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in O… (NCT05726318) | Clinical Trial Compass
CompletedPhase 4
Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women
United States70 participantsStarted 2023-02-17
Plain-language summary
To evaluate the feasibility of recruiting eligible subjects into a randomized trial of a culture-directed versus empiric antibiotic strategy for patient-reported urinary tract infection symptoms in older women and the adherence to study procedures.
Who can participate
Age range65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female biologic Sex
* Age ≥65 years old
* History of recurrent UTI per patient report of greater than 2 UTIs in the last 6 months or 3 UTIs in the last year
* Patient reported UTI defined as:
* Dysuria, increased urinary urgency/frequency and/or suprapubic pain
Exclusion Criteria:
* Male biologic sex
* Age \<65 years old
* History of augmentation cystoplasty or cystectomy
* Currently performing clean intermittent self-catheterization
* Current indwelling foley catheter
* Urinary tract instrumentation (i.e., cystourethroscopy, foley catheter placement) in the last 30 days
* Undergoing treatment for malignancy
* History of either confirmed or patient reported pyelonephritis and/or urosepsis
* Cirrhosis and/or end stage liver disease
* Chronic kidney disease with most recent estimated glomerular filtration rate \<50 ml/min
* Dementia and/or currently reside in skilled nursing facility
* Current high-dose chronic steroids (\>20mg/day of prednisone)
* Previous solid organ transplant
* Provider concern for pyelonephritis and/or sepsis (i.e., fevers)
* Unwilling or unable to comply with study procedures
What they're measuring
1
Eligible Subjects That Were Enrolled in the Study
Timeframe: Through study completion, an average of 17.5 months