Treatment and/or Prevention of Urinary Tract Infections

NCT ID: NCT00801021

Last Updated: 2010-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-06-30

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.

Conditions

Cystitis; Urinary Tract Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Frio Oral Rinse

Prescription Mouth Rinse

Group Type: EXPERIMENTAL

Frio Mouth Rinse

Intervention Type: DRUG

Rinse with 15ml twice daily then expectorate

Interventions

Frio Mouth Rinse

Rinse with 15ml twice daily then expectorate

Intervention Type: DRUG

Other Intervention Names

Prescription Mouth Rinse

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

Biomedical Development Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Baylor College of Medicine

Principal Investigators

Barbara W. Trautner, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Ben Taub General Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

1R41DK082089-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-23281

Identifier Type: -

Identifier Source: org_study_id