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

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

Study Overview

• Status: Completed
• Conditions: Cystitis; Urinary Tract Infections
• Intervention / Treatment: Drug: Frio 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Frio Oral Rinse; Prescription Mouth Rinse	Drug: Frio Mouth Rinse; Rinse with 15ml twice daily then expectorate; Other Names: Prescription Mouth Rinse

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Biomedical Development Corporation
• Collaborators: Baylor College of Medicine; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Barbara W. Trautner, M.D., Ph.D., Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (Estimate): December 3, 2008

Study Record Updates

• Last Update Posted (Estimate): March 8, 2010
• Last Update Submitted That Met QC Criteria: March 4, 2010
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Urinary Tract Infections; Cystitis
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Disease Attributes; Cystitis; Infections; Communicable Diseases; Urinary Tract Infections
• Other Study ID Numbers: H-23281; 1R41DK082089-01 (U.S. NIH Grant/Contract)