A Phase 3 interventional study of Antibiotics in Urinary Tract Infection (Diagnosis), sponsored by Megan Bradley. Not yet recruiting at 1 site in United States. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Megan Bradley · Phase 3, Interventional, and Treatment
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.
Complete a 3-arm randomized pilot trial of either empiric, urinalysis-directed or culture-directed management for UTI symptoms in older women (≥age 65 years old) with a history of recurrent UTI. We will recruit and enroll 90 women with a history of rUTI from the University of Pittsburgh Medical Center - Women's Center for Bladder and Pelvic Health and the Pitt+Me® Research Registry. Once enrolled and randomized, women will be followed for a total of 28 days.
753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.
This study's planned enrollment of 90 is below the median of 130 across 524 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Megan Bradley is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient reported UTI defined as:
Exclusion Criteria:
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
Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h.
Drug: Antibiotics
Participants will be directed to refrain from taking antibiotics until results of urinalysis reported, which is expected within 12-24 hours
Drug: 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
Clinical Success at 14 Days
Score of \<1 on question 1 (urinary burning),3 (urinary urgency) and 5 (urinary frequency) on Urinary Tract Infection Symptom Assessment at day 14. A lower scale correlates with better symptoms with 0 being no symptoms and 1 being "little" symptoms.
Time frame: 14 days
UTI sequelae
Proportion of those with either ED visit, pyelonephritis or sepsis within 30 days from study start
Time frame: 30 days
Positive urine cultures
Proportion of participants with positive urine cultures
Time frame: 5 days
Change from Baseline in Recurrent Urinary Tract Infection Symptom Scale Score at 14 Days
Score on the Recurrent Urinary Tract Infection Symptom Scale from baseline to 14 day follow-up. This scale has 11 questions with range from 0-10 so the total score is a sum and could range from 0 to 110 (reported as total score). Higher scores represent worse symptoms.
Time frame: 14 days
Antibiotic appropriateness of Current Therapy
Of those that received antibiotics, how many had a positive culture susceptible to the prescribed antibiotic
Time frame: 5 days
Plan to share: No — At this time there is no plan to share IPD.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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