Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women
Completed · Phase 4
Conditions studied: UTI
In brief
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.
Key facts
- Study ID
- NCT05726318
- Run by
- Megan Bradley
- People needed
- 70
- Starts
- 2023-02-17
- Expected to finish
- 2024-08-02
- Last updated by the study team
- 2025-08-27
Who can join
Age: 65 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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