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

Nitric BioTherapeutics

Status and phase

Terminated

Phase 2

Conditions

Methicillin-resistant Staphylococcus Aureus Infection

Skin Ulcers

Treatments

Drug: Nitric Oxide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00790608

CTP 5

EudraCT 2008-001287-36

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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