Back to resultsReduction of Bacteria in MRSA Positive Ulcers
Primary Purpose
Leg Ulcer, Pressure Ulcer
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Nitric Oxide
Sponsored by
About this trial
This is an interventional treatment trial for Leg Ulcer
Eligibility Criteria
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
Sites / Locations
- Vancouver General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nitric Oxide
Arm Description
gaseous nitric oxide delivered topically for 30 minutes
Outcomes
Primary Outcome Measures
Reduction in bacteria
Secondary Outcome Measures
Incidence of adverse events
Full Information
NCT ID
NCT00771368
First Posted
October 10, 2008
Last Updated
January 18, 2012
Sponsor
Nitric BioTherapeutics, Inc
1. Study Identification
Unique Protocol Identification Number
NCT00771368
Brief Title
Reduction of Bacteria in MRSA Positive Ulcers
Official Title
A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
limited recruitment
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nitric BioTherapeutics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer, Pressure Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nitric Oxide
Arm Type
Experimental
Arm Description
gaseous nitric oxide delivered topically for 30 minutes
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Intervention Description
1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days
Primary Outcome Measure Information:
Title
Reduction in bacteria
Time Frame
Post Treatment Day 3
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Reduction of Bacteria in MRSA Positive Ulcers
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