Overview

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