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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovaBay Pharmaceuticals, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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