Recruiting
Phase 3

Antibiotics, Urinalysis, Culture-Directed Care

Sponsor:

Megan Bradley

Code:

NCT07686055

Conditions

Urinary Tract Infection (Diagnosis)

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Antibiotics

Study Details

Brief summary:

This project aims to improve the diagnosis and management of urinary tract symptoms in older women by comparing three common treatment strategies-empiric antibiotics, urinalysis-guided therapy, and culture-directed care-in a randomized trial. By integrating patient-reported outcomes, laboratory data, the study will identify which patients benefit from antibiotics and which can safely avoid them. Findings will inform precision care strategies and promote antibiotic stewardship while improving symptom outcomes and quality of life in this high-risk population.

Conditions

Urinary Tract Infection (Diagnosis)

Study ID

NCT07686055

Start date

Jul 23, 2026

Status verified date

Oct, 2026

Completion date

Feb 14, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 65+

Healthy Volunteers: Not accepted

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 (including ability to complete electronic questionnaires)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empiric (Immediate) Antibiotic Treatment

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.

experimental: Culture-directed Antibiotic Treatment

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

experimental: Urinalysis-directed Antibiotic Treatment

Participants will be directed to refrain from taking antibiotics until results of urinalysis reported, which is expected within 12-24 hours

Interventions

Antibiotics

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 outcome measure

  • Clinical Success at 14 Days [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Megan S Bradley, MD MSc

412-641-7850bradleym4@upmc.edu

Locations

UPMC-Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Megan S Bradley, MD, MSc

412-641-7850bradleym4@upmc.edu

Principal Investigator:

Megan Bradley, MD, MSc

More Information

Sponsor

Megan Bradley

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Urinary Tract Infection
  • Women
  • Older

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Megan Bradley on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.