UTIPhase 4REDUCTIONNCT05726318
Randomized Trial of Culture Directed Versus Empiric Antibiotics for Urinary Tract Infections in Older Women
A Phase 4 study testing Antibiotics in people with UTI, run by Megan Bradley at 1 site in United States.
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 urinary tract infection symptoms in older women and the adherence to study procedures. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- UTI
- What is being tested?
- Antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2023to 2 Aug 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
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
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.
Read the 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.
- Conditions
- UTI
- Being tested
- Antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Culture-directed antibiotic | Other | Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. Receives: Drug: Antibiotics |
| Empiric antibiotic | Active comparator | 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. Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligible Subjects That Were Enrolled in the Study
Number and proportion of eligible subjects that were enrolled in the study
Measured: Through study completion, an average of 17.5 months
Secondary outcomes (9)
Number of Persons That Were Screened for Participation
Overall number of persons that were screened for participation
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Monthly Enrollment Rate
number of participants that were enrolled each month
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Proportion of Enrolled Participants That Completed Electronic Surveys
Number of persons enrolled who completed all electronic surveys divided by number participants enrolled
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start17 Feb 2023
- Primary completion2 Aug 2024
- Study completion2 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UTIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Megan Bradley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Megan Bradley, University of Pittsburgh
- Investigators
- Megan S Bradley, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726318
- Sponsor's protocol ID
- STUDY22060176
- Other IDs
- DK131273, R01DK131273
- Acronym
- REDUCTION
- Status last verified
- Aug 2025
- First submitted
- 19 Jan 2023
- Last updated
- 27 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will review each request individually and work with University of Pittsburgh Research Agreements to share.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05726318
- Acronym / sponsor ID
- REDUCTION / STUDY22060176
- Conditions
- UTI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Megan BradleyUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 2 Aug 2024 (actual)
- Study completion
- 2 Aug 2024 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Posted 27 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culture-directed antibiotic | Other | Drug: AntibioticsParticipants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. |
| Empiric antibiotic | Active comparator | Drug: AntibioticsAntibiotic 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (15 listed)
- Male biologic sex
- Age <65 years old
- History of augmentation cystoplasty or cystectomy
- Currently performing clean intermittent self-catheterization
- Current indwelling foley catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsParticipants 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 | Drug | Culture-directed antibiotic, Empiric antibiotic |
Primary outcome
Eligible Subjects That Were Enrolled in the Study
Time frame: Through study completion, an average of 17.5 months
Number and proportion of eligible subjects that were enrolled in the study
9 secondary outcomes
Number of Persons That Were Screened for Participation
Time frame: Through study completion, an average of 17.5 months
Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria
Time frame: 30 days
Proportion of Persons Screened Who Declined Participation or Were Ineligible
Time frame: 30 days
Proportion of Participants Enrolled Who Completed the Study
Time frame: 30 days
Monthly Enrollment Rate
Time frame: Through study completion, an average of 17.5 months
Proportion of Enrolled Participants That Completed All Study Procedures
Time frame: 30 days
Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms
Time frame: 30 days
Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms
Time frame: 30 days
Proportion of Enrolled Participants That Completed Electronic Surveys
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Will review each request individually and work with University of Pittsburgh Research Agreements to share.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan S Bradley principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotics in people with UTI, run by Megan Bradley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligible Subjects That Were Enrolled in the Study (time frame: Through study completion, an average of 17.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.