Clinical trial NCT00801021: Treatment and/or Prevention of Urinary Tract Infections
Official title: Treatment and/or Prevention of Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystitis
Urinary Tract Infections
Keywords: Cystitis
Urinary Tract Infections
Lead sponsor: Biomedical Development Corporation
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Baylor College of Medicine
First posted: 2008-12-03
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The primary efficacy endpoint is the reduction of the baseline pathogen at the Days 7 to 10 "Test of Cure" visit.
timeFrame: 7 to 10 Days
Secondary outcomes:
measure: The secondary efficacy endpoint of microbiological evaluation classified into four categories (i.e., Eradication, Persistence, Superinfection, and New Infection)
timeFrame: 28-35 Days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Barbara W. Trautner, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: