Status:
COMPLETED
Safety and Efficacy Study of NVC-422 on Bacteriuria in Catheterized Patients
Lead Sponsor:
NovaBay Pharmaceuticals, Inc.
Conditions:
Asymptomatic Bacteriuria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.
Detailed Description
Catheter-associated urinary tract infection (CAUTI) is a major healthcare problem in the U.S., accounting for approximately 40% of all hospital acquired infections. Microorganisms can colonize the cat...
Eligibility Criteria
Inclusion
- Patients or their guardians are willing and able to provide informed consent
- Age \> 18 years
- Condition requiring chronic transurethral catheterization for at least 1 month prior to enrollment
- Indwelling transurethral catheter not scheduled for exchange for at least 1 week from first treatment
- Documented asymptomatic bacteriuria as defined in the protocol
- Vital signs within the following limits: blood pressure 90 to 160 mm Hg systolic and 50 to100 mm Hg diastolic, pulse rate 45 to 100 bpm, respiratory rate 8 to 24 respirations per minute, oral body temperature 35.5ºC to 38.0ºC
- Screening must occur within 14 days of enrollment into the study
Exclusion
- Unwillingness/inability to fulfill the requirements of the study
- History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease
- Systemic antibiotics within 7 days of enrollment
- Any condition that, in the opinion of the principal investigator, would make the subject unsuitable for the study or place the subject at additional risk.
- Any investigational drug or investigational device within 30 days of enrollment in the study
- Women who are pregnant or lactating; or of child-bearing potential unless using highly effective birth control method for 1 month prior to and during the study
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00781339
Start Date
October 1 2008
End Date
March 1 2010
Last Update
September 12 2011
Active Locations (1)
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1
Michael E. Debakey V.A. Medical Center
Houston, Texas, United States, 77030