Overview

Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)

Status:
Terminated
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to determine if topically applied nitric oxide gas is effective in reducing the quantity of bacteria (including MRSA)in a wound.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nitric BioTherapeutics, Inc
Treatments:
Methicillin
Nitric Oxide
Criteria
Inclusion Criteria:

- Must have given written informed consent

- Must be ≥ 18 years of age and not of child bearing potential

- Must have an ulcer in which the presence of MRSA has been identified, but which is not
clinically infected

- Must have an ulcer size not to extend beyond the inner borders of the dressing

Exclusion Criteria:

- Is a female of child bearing years or who could become pregnant

- Is < 18 years of age

- Has an clinically infected skin ulcer

- Has a ulcer that is being treated with a topical antimicrobial agent or has been
treated with a topical antimicrobial agent during 3 days prior to enrolment

- Has been using systemic antibiotics during 7 days prior to enrolment into this study

- Has an ulcer which is identified as malignant in origin (e.g. Marjolin's ulcer)

- Has an ulcer size beyond the inner borders of the dressing

- Is septic or has other signs of an invasive infection

- Has used any investigational drug within 30 days preceding study participation.

- Suffers from a condition, which, in the opinion of the Investigator, would compromise
his or her safety.

- Suffers from a condition which, in the opinion of the Investigator, would compromise
the quality of the data.

- Has a known allergy to any of the products that are part of this protocol

- Suffers from a condition which, in the opinion of the Investigator, would seriously
interfere negatively with the normal parameters of immune response to an infection.

- Is using any of the prohibited concomitant medications or treatments