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

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Megan Bradley
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Anti-Bacterial Agents

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 <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