Treatment and/or Prevention of Urinary Tract Infections

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biomedical Development Corporation
• Collaborators: Baylor College of Medicine; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.