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NCT Number: NCT05726318

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

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.

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Key information

Conditions

UTI

Age range

65 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotics

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Persons That Were Screened for Participation

    Time frame: Through study completion, an average of 17.5 months

    Overall number of persons that were screened for participation

  2. Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria

    Time frame: 30 days

    Number of person screened who met include/exclusion criteria divided by number participants screened

  3. Proportion of Persons Screened Who Declined Participation or Were Ineligible

    Time frame: 30 days

    Number of person screened who declined or were ineligible divided by number participants screened

  4. Proportion of Participants Enrolled Who Completed the Study

    Time frame: 30 days

    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

  5. Monthly Enrollment Rate

    Time frame: Through study completion, an average of 17.5 months

    number of participants that were enrolled each month

  6. Proportion of Enrolled Participants That Completed All Study Procedures

    Time frame: 30 days

    Number of persons enrolled who completed all study procedures (completed all 4 follow-up questionnaires) divided by number participants enrolled

  7. Proportion of Enrolled Participants That Took Alternative Agents for Management of Symptoms

    Time frame: 30 days

    Number of persons enrolled who took alternative agents for management of symptoms divided by number participants enrolled

  8. Proportion of Participants in the Culture-directed Arm That Acquired Off-protocol Antibiotics for Their Symptoms

    Time frame: 30 days

    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

  9. Proportion of Enrolled Participants That Completed Electronic Surveys

    Time frame: 30 days

    Number of persons enrolled who completed all electronic surveys divided by number participants enrolled

Other outcomes

  1. Clinical Success at 14 Days

    Time frame: 14 days

    Score of <1 on question 1 (urinary burning),3 (urinary urgency) and 5 (urinary frequency) on Urinary Tract Infection Symptom Assessment at day 14. A lower scale correlates with better symptoms with 0 being no symptoms and 1 being "little" symptoms.

Sponsors and collaborators

Lead sponsor

Megan Bradley

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study 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

Acronym: REDUCTION

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2023
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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