A Phase II Trial on the Reduction of Meticillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers

• Conditions: lcers in which the presence of meticillin resistant Staphylococcus aureus (MRSA) has been identified.; MedDRA version: 9.1Level: LLTClassification code 10045285Term: Ulcer

• Registration Number: EUCTR2008-001287-36-GB
• Lead Sponsor: itric BioTherapeutics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Subject:
- Must have given written informed consent
- Must be 18 years of age or over and, if female, not of child bearing potential
- Must have an ulcer in which the presence of MRSA has been positively identified but which is not clinically infected.
- Must have an ulcer size not to extend beyond the inner borders of the dressing.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject:
-Is pregnant or a female who could become pregnant
- Is < 18 years of age
- Has a clinically infected ulcer
- Has an ulcer that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment.
- Is using systemic antibiotics or 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 product 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
- Is immune deficient
- Is using any of the prohibited concomitant medications or treatments

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of topically applied gaseous nitric oxide to reduce microorganisms including MRSA. ;Secondary Objective: To determine the effect of the application of gaseous nitric oxide on the condition of the ulcer.<br><br>To determine the safety of the treatment as measured by the incidence of adverse events.;Primary end point(s): A 3-Log (or better) reduction in microorganisms including MRSA.