# 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

> **NIH NIH R01** · MAGEE-WOMEN'S RES INST AND FOUNDATION · 2024 · $311,517

## Abstract

PROJECT ABSTRACT
Urinary tract infections (UTIs) account for significant morbidity on both an individual and societal level. UTIs are
especially common in older women and a subset are prone to recurrent UTIs (rUTIs). Current understanding of
the natural progression of patient reported UTIs in older women with rUTI is limited due to low levels of
inclusion in previous randomized controlled trials on initial non-antibiotic strategies. For Aim 1: We seek to
evaluate the feasibility of recruiting eligible participants 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. We will explore the safety of a culture-directed UTI treatment strategy and preliminary secondary
outcomes of assigned treatments. For Aim 2: We will investigate previous UTI experiences and acceptability of
trial design/future recruitment efforts via focus groups with women that are recruited for the pilot trial and also
among key community stakeholders. For Aim 3, we will assess facilitators and barriers with trial
implementation and recruitment through semi-structured interviews among both participating and
representative non-participating providers. We plan to recruit older women with rUTI through both our clinical
practice and the University of Pittsburgh’s Clinical and Translational Science Institute (CTSI) Pitt+Me®
Research Registry. When symptomatic for UTI, a total of 70 women will be enrolled and randomized to either a
culture-directed or empiric antibiotic strategy. Those in the empiric arm will be prescribed antibiotics following a
standard protocol and those in the culture-directed arm will have antibiotics prescribed based on urine culture
and sensitivity results that return in ~48-72 hours. At baseline, subjects will complete demographic and
symptom questionnaires. Subjects will be followed when urine culture results are available and then weekly
until they are 28 days from symptom onset (with electronic survey and phone call). Follow-up questions will
investigate symptom resolution, antibiotic side effects, and any treatment for progression of symptoms (either
pyelonephritis or urosepsis). Subjects will have contact information to a member of our team that is available
24/7. A total of 30 women (10 who complete study, 10 who declined participation and 10 community
stakeholders) will be interviewed through focus groups to ensure the patient-voice is taken into consideration
on future trial planning. We will additionally recruit providers (10 of those who participated in recruitment and
10 non-recruiting providers) to complete semi-structured, qualitative interviews on their trial experiences. Our
mixed-methods pilot study will generate the requisite preliminary feasibility, acceptability, efficacy/proof of
concept, and safety data to inform the design of a definitive randomized trial of a culture-directed versus
empiric antibiotic strategy for the treatmen...

## Key facts

- **NIH application ID:** 10756553
- **Project number:** 5R01DK131273-02
- **Recipient organization:** MAGEE-WOMEN'S RES INST AND FOUNDATION
- **Principal Investigator:** Megan Bradley
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $311,517
- **Award type:** 5
- **Project period:** 2023-01-01 → 2025-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10756553

## Citation

> US National Institutes of Health, RePORTER application 10756553, 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 (5R01DK131273-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10756553. Licensed CC0.

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