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| Name | Class |
|---|---|
| American Association of Obstetricians and Gynecologists Foundation (AAOGF) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| UTI sequelae | Proportion of those with either ED visit, pyelonephritis or sepsis within 30 days from study start | 30 days |
| Positive urine cultures | Proportion of participants with positive urine cultures |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan S Bradley, MD MSc | Contact | 412-641-7850 | bradleym4@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Megan Bradley, MD, MSc | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC-Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
At this time there is no plan to share IPD.
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D004194 | Disease |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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| 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. | 14 days |
| Antibiotic appropriateness of Current Therapy | Of those that received antibiotics, how many had a positive culture susceptible to the prescribed antibiotic | 5 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |