Phase 4
N=70
Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women
UTI
Bottom Line
View on ClinicalTrials.gov: NCT05726318 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Eligible Subjects That Were Enrolled in the Study — 70 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Antibiotics (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Megan Bradley
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Eligible Subjects That Were Enrolled in the Study |
70 | — |
| SECONDARY Number of Persons That Were Screened for Participation |
131 | — |
| SECONDARY Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria |
103 | — |
| SECONDARY Proportion of Persons Screened Who Declined Participation or Were Ineligible |
43 | — |
| SECONDARY Proportion of Participants Enrolled Who Completed the Study |
30; 31 | .78 |
| SECONDARY Monthly Enrollment Rate |
4 | — |
| SECONDARY Proportion of Enrolled Participants That Completed All Study Procedures |
30; 31 | .78 |
| SECONDARY Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms |
16; 10 | .68 |
| SECONDARY Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms |
1 | — |
| SECONDARY Proportion of Enrolled Participants That Completed Electronic Surveys |
30; 31 | .78 |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05726318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.