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Reduction of Bacteria in MRSA Positive Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771368
Recruitment Status : Terminated (limited recruitment)
First Posted : October 13, 2008
Last Update Posted : January 19, 2012
Information provided by:
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

Condition or disease Intervention/treatment Phase
Leg Ulcer Pressure Ulcer Drug: Nitric Oxide Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions
Study Start Date : January 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Nitric Oxide
gaseous nitric oxide delivered topically for 30 minutes
Drug: Nitric Oxide
1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days

Primary Outcome Measures :
  1. Reduction in bacteria [ Time Frame: Post Treatment Day 3 ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 3 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00771368

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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Nitric BioTherapeutics, Inc

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Responsible Party: President & CEO, Nitric BioTherapeutics, Inc. Identifier: NCT00771368     History of Changes
Other Study ID Numbers: CTP 7
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
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Leg Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents