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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41DK082089-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Baylor College of Medicine | OTHER |
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The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.
A 7-day treatment with a 28-day follow up has been designed as a "before and after" assessment of the clinical signs and symptoms of an uncomplicated urinary tract infection and the reduction/eradication of urinary pathogens. Enrollment is targeted to achieving 20 evaluable subjects by the end of the study. After enrolling in the trial at Day 0 (first day of dosing), participants will report back to the study site at Days 3, 7, and 28. At Day 3 or any time thereafter, worsening of symptoms and/or increases in quantitative bacteria counts will result in removal from the trial and prescription of a rescue medication, which will be selected based on microbial susceptibility testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frio Oral Rinse | Experimental | Prescription Mouth Rinse |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frio Mouth Rinse | Drug | Rinse with 15ml twice daily then expectorate |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit. | 7 to 10 Days |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection) | 28-35 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara W. Trautner, M.D., Ph.D. | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Taub General Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D003556 | Cystitis |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |