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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Management of Urinary Tract Symptoms in Older Women: A Randomized Trial to Reduce Overtreatment
- ClinicalTrials.gov ID
- NCT07686055
- Acronym / sponsor ID
- GUIDE-UTI / STUDY26050198
- Conditions
- Urinary Tract Infection (Diagnosis)
- Keywords
- Urinary Tract Infection, Women, Older
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Megan BradleyUniversity, hospital or other
- Collaborators
- American Association of Obstetricians and Gynecologists Foundation (AAOGF)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Empiric (Immediate) Antibiotic Treatment | Experimental | Drug: AntibioticsAntibiotic 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. |
| Culture-directed Antibiotic Treatment | Experimental | Drug: AntibioticsParticipants will be directed to refrain from taking antibiotics until results of urine culture are reported, which is expected within 48-72h. |
| Urinalysis-directed Antibiotic Treatment | Experimental | Drug: AntibioticsParticipants will be directed to refrain from taking antibiotics until results of urinalysis reported, which is expected within 12-24 hours |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (15 listed)
- Male biologic sex
- Age <65 years old
- History of augmentation cystoplasty or cystectomy
- Currently performing clean intermittent self-catheterization
- Current indwelling foley catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsParticipants 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 | Drug | Culture-directed Antibiotic Treatment, Empiric (Immediate) Antibiotic Treatment, Urinalysis-directed Antibiotic Treatment |
Primary outcome
Clinical Success at 14 Days
Time frame: 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.
4 secondary outcomes
UTI sequelae
Time frame: 30 days
Positive urine cultures
Time frame: 5 days
Change from Baseline in Recurrent Urinary Tract Infection Symptom Scale Score at 14 Days
Time frame: 14 days
Antibiotic appropriateness of Current Therapy
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. At this time there is no plan to share IPD.
Related trials for Urinary Tract Infection (Diagnosis)
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VA Quality Enhancement Research Initiative (QUERI) CARRIAGE VAST
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Prediction and Prevention of Bloodstream Infections After Kidney Transplantation
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Urine Collection and Novel UTI Biomarkers in Children and Older Adults
UTI - Urinary Tract Infection
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A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
Chronic Urinary Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Megan Bradley, MD, MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antibiotics in people with Urinary Tract Infection (Diagnosis), run by Megan Bradley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan S Bradley, MD MSc (412-641-7850, bradleym4@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success at 14 Days (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.