Status:
COMPLETED
Treatment and/or Prevention of Urinary Tract Infections
Lead Sponsor:
Biomedical Development Corporation
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Baylor College of Medicine
Conditions:
Cystitis
Urinary Tract Infections
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
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/eradicat...
Eligibility Criteria
Inclusion
- Non-pregnant adult females;
- 18 years of age or older;
- 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;
- One positive dipstick urine test positive either for leukocyte esterase or nitrates or have a urinalysis with \> 5 wbc/hpf.
- A pre-treatment clean-catch midstream urine culture with ≥ 104 CFU/mL of a bacterial organism
Exclusion
- Males;
- Women who are pregnant, nursing, or not using a medically accepted, effective method of birth control;
- Three or more episodes of acute uncomplicated UTI in the past 12 months;
- Known structural abnormality that would predispose the participant to reflux or urinary retention;
- 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;
- Patients with significant impaired immunity secondary to chemotherapy, oral corticosteroids, or HIV;
- Patients with onset of symptoms \> 72 hours prior to entry;
- Patients with a temperature ≥ 100°F, flank pain, chills, or any other manifestations suggestive of upper urinary tract infection;
- Patients with purported hypersensitivity to iodine;
- Patients with history of thyroid disease;
- Patients who received treatment with other antimicrobials within 48 hours prior to entry;
- 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;
- Use of concomitant medication that, in the opinion of the Study Directors, might interfere with the outcome of the study.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00801021
Start Date
December 1 2008
End Date
June 1 2009
Last Update
March 8 2010
Active Locations (1)
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1
Ben Taub General Hospital
Houston, Texas, United States, 77030