Overview

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.