Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)

This study has been terminated.
(Limited recruitment)
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc Identifier:
First received: November 12, 2008
Last updated: November 28, 2011
Last verified: November 2011

The purpose of the study is to determine if topically applied nitric oxide gas is effective in reducing the quantity of bacteria (including MRSA)in a wound.

Condition Intervention Phase
Skin Ulcers
Methicillin-resistant Staphylococcus Aureus Infection
Drug: Nitric Oxide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers

Resource links provided by NLM:

Further study details as provided by Nitric BioTherapeutics, Inc:

Primary Outcome Measures:
  • Change in bioburden (specifically MRSA)as assessed via quantitative cultures. [ Time Frame: 10 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 10 Days ] [ Designated as safety issue: Yes ]

Enrollment: 8
Study Start Date: January 2009
Study Completion Date: August 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Nitric Oxide
    Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must have given written informed consent
  • Must be ≥ 18 years of age and not of child bearing potential
  • Must have an ulcer in which the presence of MRSA has been identified, but which is not clinically infected
  • Must have an ulcer size not to extend beyond the inner borders of the dressing

Exclusion Criteria:

  • Is a female of child bearing years or who could become pregnant
  • Is < 18 years of age
  • Has an clinically infected skin ulcer
  • Has a ulcer that is being treated with a topical antimicrobial agent 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 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 drug 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00790608

United Kingdom
Department of Wound Healing, Cardiff University
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
Nitric BioTherapeutics, Inc
Principal Investigator: Keith Harding, MB ChB, MRGCP, FRCS Department of Wound Healing, Cardiff University
  More Information

No publications provided

Responsible Party: Nitric BioTherapeutics, Inc Identifier: NCT00790608     History of Changes
Other Study ID Numbers: CTP 5, EudraCT 2008-001287-36
Study First Received: November 12, 2008
Last Updated: November 28, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Skin Ulcer
Staphylococcal Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Skin Diseases
Nitric Oxide
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Endothelium-Dependent Relaxing Factors
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasodilator Agents processed this record on February 26, 2015