Treatment and/or Prevention of Urinary Tract Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment and/or Prevention of Urinary Tract Infections

Conditions
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Cystitis, Urinary Tract Infections

Intervention / Treatment
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* Drug: Frio Mouth Rinse


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Frio Oral Rinse<br>Prescription Mouth Rinse | Drug: Frio Mouth Rinse<br>* Rinse with 15ml twice daily then expectorate<br>* Other names: Prescription Mouth Rinse;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystitis, Urinary Tract Infections