Precision Management of Urinary Tract Symptoms in Older Women

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Megan Bradley
Study ID
NCT07686055
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Urinary Tract Infection (Diagnosis)

Eligibility Criteria

Sex
FEMALE
Age
65 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jul 14, 2026
Status verified
Jun 2026
Primary completion
Feb 1, 2027
Completion
Feb 14, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC-Magee Womens HospitalPittsburghPennsylvania15213
Megan S Bradley, MD, MSc
[email protected]
412-641-7850
Megan Bradley, MD, MSc (PRINCIPAL_INVESTIGATOR)

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By research site
UPMC-Magee Womens Hospital· Pittsburgh, PA

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