Treatment and/or Prevention of Urinary Tract Infections (UTI)

Biomedical Development Corporation

Status and phase: Completed; Phase 1

Conditions: Urinary Tract Infections; Cystitis

Treatments: Drug: Frio Mouth Rinse

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT00801021

1R41DK082089-01 (U.S. NIH Grant/Contract)

H-23281

Details and patient eligibility

About

The purpose of the study is to determine the effect of an investigational oral rinse in reducing uropathogens and treating uncomplicated urinary tract infections.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Frio Oral Rinse

Experimental group

Description:

Prescription Mouth Rinse

Treatment:

Drug: Frio Mouth Rinse