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

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

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.

Study Overview

• Status: Completed
• Conditions: UTI
• Intervention / Treatment: Drug: Antibiotics

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 urinary tract infection (UTI) symptoms in older women and B) the adherence to study procedures. We will recruit and enroll women with a history of recurrent UTI (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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Culture-directed antibiotic; Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h.	Drug: Antibiotics; Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 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
Active Comparator: Empiric antibiotic; Antibiotic Protocol. For participants in the empiric Rx arm, we will choose an antibiotic with consideration of patient reported allergies, current medications and current Infectious Disease Society of American (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; Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days, trimethoprim/sulfamethoxazole 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eligible Subjects That Were Enrolled in the Study	Number and proportion of eligible subjects that were enrolled in the study	Through study completion, an average of 17.5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Persons That Were Screened for Participation	Overall number of persons that were screened for participation	Through study completion, an average of 17.5 months
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 (at least one follow-up questionnaire and completed the day 28 questionnaire) divided by number participants enrolled	30 days
Monthly Enrollment Rate	number of participants that were enrolled each month	Through study completion, an average of 17.5 months
Proportion of Enrolled Participants That Completed All Study Procedures	Number of persons enrolled who completed all study procedures (completed all 4 follow-up questionnaires) 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success at 14 Days	Score of <1 on question 1 (urinary burning),3 (urinary urgency) and 5 (urinary frequency) on Urinary Tract Infection Symptom Assessment at day 14. A lower scale correlates with better symptoms with 0 being no symptoms and 1 being "little" symptoms.	14 days

Collaborators and Investigators

• Sponsor: Megan Bradley
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Megan S Bradley, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): August 2, 2024
• Study Completion (Actual): August 2, 2024

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Urinary Tract Infections; Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Bacterial Agents
• Other Study ID Numbers: STUDY22060176; DK131273 (Other Identifier: NIDDK); R01DK131273 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will review each request individually and work with University of Pittsburgh Research Agreements to share.
• IPD Sharing Time Frame: 1 year after completion
• IPD Sharing Access Criteria: unknown at this time
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No