Treatment and/or Prevention of Urinary Tract Infections (UTI)
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Purpose
The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.
| Condition | Intervention | Phase |
|---|---|---|
|
Cystitis Urinary Tract Infections |
Drug: Frio Mouth Rinse |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Treatment and/or Prevention of Urinary Tract Infections |
- The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit. [ Time Frame: 7 to 10 Days ] [ Designated as safety issue: Yes ]
- The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection) [ Time Frame: 28-35 Days ] [ Designated as safety issue: Yes ]
| Enrollment: | 3 |
| Study Start Date: | December 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Frio Oral Rinse
Prescription Mouth Rinse
|
Drug: Frio Mouth Rinse
Rinse with 15ml twice daily then expectorate
Other Name: Prescription Mouth Rinse
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non-pregnant adult females;
- 18 years of age or older;
- Clinical signs with one or more symptoms of a UTI (e.g., dysuria, frequency, urgency, suprapubic pain) with onset of symptoms < 72 hours prior to study entry;
- One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with > 5 wbc/hpf.
- A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism
Exclusion Criteria:
- Males;
- Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control;
- Three or more episodes of acute uncomplicated UTI in the past 12 months;
- Known structural abnormality that would predispose the participant to reflux or urinary retention;
- Patients with evidence of factors predisposing to the development of urinary tract infections, including calculi, stricture, primary renal disease (e.g., polycystic renal disease), or neurogenic bladder;
- Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV;
- Patients with onset of symptoms > 72 hours prior to entry;
- Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection;
- Patients with purported hypersensitivity to iodine;
- Patients with history of thyroid disease;
- Patients who received treatment with other antimicrobials within 48 hours prior to entry;
- Any significant medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; inability to use an oral rinse;
- Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of the study.
Contacts and Locations| United States, Texas | |
| Ben Taub General Hospital | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Barbara W. Trautner, M.D., Ph.D. | Baylor College of Medicine |
More Information
No publications provided
| Responsible Party: | Barbara Wells Trautner, M.D., Ph.D., Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00801021 History of Changes |
| Other Study ID Numbers: | H-23281, 1R41DK082089-01 |
| Study First Received: | December 2, 2008 |
| Last Updated: | March 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biomedical Development Corporation:
|
Cystitis Urinary Tract Infections |
Additional relevant MeSH terms:
|
Cystitis Urinary Tract Infections Urinary Bladder Diseases Urologic Diseases Infection |
ClinicalTrials.gov processed this record on June 17, 2013