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

NCT05726318 | Completed Phase 4 Results DMC FDA Drug

• 3 other identifiers: STUDY22060176DK131273R01DK131273
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

UTI

Outcome Measures

Primary Outcomes (1)

• Eligible Subjects That Were Enrolled in the Study

  Number and proportion of eligible subjects that were enrolled in the study

  Through study completion, an average of 17.5 months

Secondary Outcomes (9)

• Number of Persons That Were Screened for Participation

  Through study completion, an average of 17.5 months

• Proportion of Persons Screened Who Met Inclusion/Exclusion Criteria

  30 days

• Proportion of Persons Screened Who Declined Participation or Were Ineligible

  30 days

• Proportion of Participants Enrolled Who Completed the Study

  30 days

• Monthly Enrollment Rate

  Through study completion, an average of 17.5 months

Other Outcomes (1)

• Clinical Success at 14 Days

  14 days

Study Arms (2)

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.

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.

Drug: Antibiotics

Interventions

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

Culture-directed antibiotic; Empiric antibiotic

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Megan Bradley: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Megan Bradley, MD
• Organization: University of Pittsburgh

bradleym4@upmc.edu

412-641-3189

Study Officials

• Megan S Bradley

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 13, 2023
• Study Start: February 17, 2023
• Primary Completion: August 2, 2024
• Study Completion: August 2, 2024
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year after completion
• Access Criteria: unknown at this time

Locations

US (1)