Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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UTI

Intervention / Treatment
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* Drug: Antibiotics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Culture-directed antibiotic<br>Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. | Drug: Antibiotics<br>* Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoaxole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days<br>|
| Active Comparator: Empiric antibiotic<br>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. | Drug: Antibiotics<br>* Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoaxole 875/125 oral twice a day for 3 days, fosfomycin 3g once oral, ciprofloxacin 250 mg oral twice a day for 5 days or cephalexin 500 mg oral twice a day for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eligible participants that were enrolled in the study | Number of enrolled eligible participants divided by number participants enrolled | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of persons that were screened for participation | Number of persons that were screened for participation | 30 days | 
| Proportion of persons screened who met inclusion/exclusion criteria | Number of person screened who met include/exclusion criteria divided by number participants screened | 30 days | 
| Proportion of persons screened who declined participation or were ineligible | Number of person screened who declined or were ineligible divided by number participants screened | 30 days | 
| Proportion of participants enrolled who completed the study | Number of persons enrolled who completed the study divided by number participants enrolled | 30 days | 
| Monthly enrollment rate | number of participants that were enrolled each month divided by total person-months of screening | 30 days | 
| Proportion of enrolled participants that completed all study procedures | Number of persons enrolled who completed all study procedures divided by number participants enrolled | 30 days | 
| Proportion of enrolled participants that took alternative agents for management of symptoms | Number of persons enrolled who took alternative agents for management of symptoms divided by number participants enrolled | 30 days | 
| Proportion of participants in the culture-directed arm that acquired off-protocol antibiotics for their symptoms | 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 | 30 days | 
| Proportion of enrolled participants that completed electronic surveys | Number of persons enrolled who completed all electronic surveys divided by number participants enrolled | 30 days |