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

UTI Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05726318
Study type Interventional
Source University of Pittsburgh
Contact Megan Bradley, MD
Phone 2487701681
Email bradleym4@upmc.edu
Status Recruiting
Phase Phase 4
Start date February 17, 2023
Completion date July 2024
View Details
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