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

Megan Bradley

Status and phase: Completed; Phase 4

Conditions: UTI

Treatments: Drug: Antibiotics

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05726318

DK131273 (Other Identifier)

STUDY22060176

R01DK131273 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Culture-directed antibiotic

Other group

Description:

Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h.

Treatment:

Drug: Antibiotics

Empiric antibiotic

Active Comparator group

Description:

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.

Treatment:

Drug: Antibiotics