Clinical trial NCT05726318: Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women
Official title: A Randomized Pilot and Feasibility Study of a CultuRE-Directed Approach to Urinary TraCT Infection Symptoms in Older WomeN: a Mixed Methods Evaluation - the REDUCTION Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: UTI
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-02-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of eligible participants that were enrolled in the study
timeFrame: 30 days
Secondary outcomes:
measure: Number of persons that were screened for participation
timeFrame: 30 days
measure: Proportion of persons screened who met inclusion/exclusion criteria
timeFrame: 30 days
measure: Proportion of persons screened who declined participation or were ineligible
timeFrame: 30 days
measure: Proportion of participants enrolled who completed the study
timeFrame: 30 days
measure: Monthly enrollment rate
timeFrame: 30 days
measure: Proportion of enrolled participants that completed all study procedures
timeFrame: 30 days
measure: Proportion of enrolled participants that took alternative agents for management of symptoms
timeFrame: 30 days
measure: Proportion of participants in the culture-directed arm that acquired off-protocol antibiotics for their symptoms
timeFrame: 30 days
measure: Proportion of enrolled participants that completed electronic surveys
timeFrame: 30 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Women's Hospital of UPMC
state: Pennsylvania
Study officials:
References: