Safety and Efficacy Study of NVC-422 on Bacteriuria in Catheterized Patients

Completed · Phase 2

Conditions studied: Asymptomatic Bacteriuria

In brief

The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.

Key facts

Study ID

NCT00781339

Run by

NovaBay Pharmaceuticals, Inc.

People needed

20

Starts

2008-10-01

Expected to finish

2010-03-01

Last updated by the study team

2011-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Michael E. Debakey V.A. Medical Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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