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

UTI Clinical Trial

— REDUCTION  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05726318
• Other study ID #: STUDY22060176
• Secondary ID: DK131273
• Status: Recruiting
• Phase: Phase 4
• Start date: February 17, 2023
• Est. completion date: July 2024

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: Megan Bradley, MD
• Phone: 2487701681
• Email: bradleym4[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections
• UTI

Intervention

Drug:
• Antibiotics
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

Locations

Country	Name	City	State
United States	Magee Women's Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Megan Bradley	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of eligible participants that were enrolled in the study	Number of enrolled eligible participants divided by number participants enrolled	30 days
Secondary	Number of persons that were screened for participation	Number of persons that were screened for participation	30 days
Secondary	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
Secondary	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
Secondary	Proportion of participants enrolled who completed the study	Number of persons enrolled who completed the study divided by number participants enrolled	30 days
Secondary	Monthly enrollment rate	number of participants that were enrolled each month divided by total person-months of screening	30 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of enrolled participants that completed electronic surveys	Number of persons enrolled who completed all electronic surveys divided by number participants enrolled	30 days