Reduction of Bacteria in MRSA Positive Ulcers

Phase 1

Terminated

• Conditions: Leg Ulcer; Pressure Ulcer
• Interventions: Drug: Nitric Oxide

• Registration Number: NCT00771368
• Lead Sponsor: Nitric BioTherapeutics, Inc

Brief Summary

The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Study Start: 2009-01
• Primary Completion: 2009-05
• Study Completion: 2009-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Must have given written informed consent
• Must be 19 years of age or over
• Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.
• Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover

Exclusion Criteria

• Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)
• Is < 19 years of age
• Has a clinically infected ulcer
• Has an Ulcer / Lesion that is currently treated 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 / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer)
• Has an Ulcer / Lesion size beyond the inner borders of the wound cover
• Is septic or has other signs of an invasive infection
• Has used any other 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nitric Oxide	Nitric Oxide	gaseous nitric oxide delivered topically for 30 minutes

Primary Outcome Measures

Name	Time	Method
Reduction in bacteria	Post Treatment Day 3

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	3 days

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada