Cystitis, Urinary Tract Infections
Conditions
Keywords
Cystitis, Urinary Tract Infections
Brief summary
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
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.
Interventions
DRUGFrio Mouth Rinse
Rinse with 15ml twice daily then expectorate
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Biomedical Development Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Non-pregnant adult females; 2. 18 years of age or older; 3. 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; 4. One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with \> 5 wbc/hpf. 5. A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism
Exclusion criteria
1. Males; 2. Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control; 3. Three or more episodes of acute uncomplicated UTI in the past 12 months; 4. Known structural abnormality that would predispose the participant to reflux or urinary retention; 5. 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; 6. Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV; 7. Patients with onset of symptoms \> 72 hours prior to entry; 8. Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection; 9. Patients with purported hypersensitivity to iodine; 10. Patients with history of thyroid disease; 11. Patients who received treatment with other antimicrobials within 48 hours prior to entry; 12. 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; 13. Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of the study.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection) | 28-35 Days |
Countries
United States
Outcome results
None listed