Urinary Tract Infection (Diagnosis)Phase 3GUIDE-UTINCT07686055
Precision Management of Urinary Tract Symptoms in Older Women
A Phase 3 study testing Antibiotics in people with Urinary Tract Infection (Diagnosis), run by Megan Bradley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Urinary Tract Infection (Diagnosis)
- What is being tested?
- Antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2026to 14 Feb 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Megan S Bradley, MD, MSc, 412-641-7850, bradleym4@upmc.edu
Megan Bradley, MD, MSc
About this study
Official title: Precision Management of Urinary Tract Symptoms in Older Women: A Randomized Trial to Reduce Overtreatment
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.
Read the detailed description
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.
- Conditions
- Urinary Tract Infection (Diagnosis)
- Being tested
- Antibiotics
- Keywords
- Urinary Tract Infection, Women, Older
- Medical subject headings
- Urinary Tract Infections, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
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 group | Role | What they receive |
|---|---|---|
| Empiric (Immediate) Antibiotic Treatment | Experimental | 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. Receives: Drug: Antibiotics |
| Culture-directed Antibiotic Treatment | Experimental | Participants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. Receives: Drug: Antibiotics |
| Urinalysis-directed Antibiotic Treatment | Experimental | Participants will be directed to refrain from taking antibiotics until results of urinalysis reported, which is expected within 12-24 hours Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (4)
UTI sequelae
Proportion of those with either ED visit, pyelonephritis or sepsis within 30 days from study start
Measured: 30 days
Positive urine cultures
Proportion of participants with positive urine cultures
Measured: 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.
Measured: 14 days
Antibiotic appropriateness of Current Therapy
Of those that received antibiotics, how many had a positive culture susceptible to the prescribed antibiotic
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start23 Jul 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract Infection (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Megan Bradley
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Obstetricians and Gynecologists Foundation (AAOGF)
- Responsible party
- Sponsor-investigator, Megan Bradley, University of Pittsburgh
- Investigators
- Megan Bradley, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686055
- Sponsor's protocol ID
- STUDY26050198
- Acronym
- GUIDE-UTI
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan to share IPD.