Status:
TERMINATED
Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)
Lead Sponsor:
Nitric BioTherapeutics, Inc
Conditions:
Skin Ulcers
Methicillin-resistant Staphylococcus Aureus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00790608
Start Date
January 1 2009
End Date
August 1 2011
Last Update
November 29 2011
Active Locations (1)
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1
Department of Wound Healing, Cardiff University
Cardiff, United Kingdom, CF14 4XN