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Reduction of Bacteria in MRSA Positive Ulcers

This study has been terminated.
(limited recruitment)
Sponsor:
Information provided by:
Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00771368
First received: October 10, 2008
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Leg Ulcer
Pressure Ulcer
 Drug: Nitric Oxide
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:
  • Reduction in bacteria [ Time Frame: Post Treatment Day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771368

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

No publications provided

Responsible Party: President & CEO, Nitric BioTherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00771368     History of Changes
Other Study ID Numbers: CTP 7
Study First Received: October 10, 2008
Last Updated: January 18, 2012
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 19, 2013