Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women
- Conditions
- UTI
- Interventions
- Drug: Antibiotics
- Registration Number
- NCT05726318
- Lead Sponsor
- Megan Bradley
- Brief 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.
- Detailed Description
To evaluate A) 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 B) the adherence to study procedures. We will recruit and enroll women with a history of rUTI from the Women's Center for Bladder and Pelvic Health and the University of Pittsburgh's Clinical and Translational Science Institute (CTSI) Pitt+Me® Research Registry. Once enrolled and randomized, women will be followed for a total of 28 days to document both clinical resolution at day 7 from symptom onset and adverse events. H1) Enrolling a total of 70 subjects in \<1 year (at least 10% of eligible patients) will demonstrate feasibility of recruitment and H2) Documenting at least 70% patient compliance with study procedures will confirm patient adherence to study protocol. Exploratory Aim: To explore the safety of a culture-directed UTI treatment strategy and preliminary secondary outcomes of assigned treatments. H1) There will be an overall low number of adverse events and H2) Preliminary outcome data will help power future trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 70
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Culture-directed antibiotic Antibiotics Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. Empiric antibiotic Antibiotics Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current IDSA guidelines. If there is a contraindication to the first antibiotic on the list they will progress to the next option until a suitable selection is achieved.
- Primary Outcome Measures
Name Time Method Proportion of eligible participants that were enrolled in the study 30 days Number of enrolled eligible participants divided by number participants enrolled
- Secondary Outcome Measures
Name Time Method Proportion of participants enrolled who completed the study 30 days Number of persons enrolled who completed the study divided by number participants enrolled
Monthly enrollment rate 30 days number of participants that were enrolled each month divided by total person-months of screening
Proportion of enrolled participants that completed all study procedures 30 days Number of persons enrolled who completed all study procedures divided by number participants enrolled
Proportion of enrolled participants that took alternative agents for management of symptoms 30 days Number of persons enrolled who took alternative agents for management of symptoms divided by number participants enrolled
Proportion of persons screened who declined participation or were ineligible 30 days Number of person screened who declined or were ineligible divided by number participants screened
Number of persons that were screened for participation 30 days Number of persons that were screened for participation
Proportion of persons screened who met inclusion/exclusion criteria 30 days Number of person screened who met include/exclusion criteria divided by number participants screened
Proportion of participants in the culture-directed arm that acquired off-protocol antibiotics for their symptoms 30 days Number of participants in the culture-directed arm that acquired off-protocol antibiotics for their symptoms divided by the number of participants in the culture-directed arm
Proportion of enrolled participants that completed electronic surveys 30 days Number of persons enrolled who completed all electronic surveys divided by number participants enrolled
Trial Locations
- Locations (1)
Magee Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States