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

This study has been terminated.
(Limited recruitment)
Sponsor:
Information provided by (Responsible Party):
Nitric BioTherapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00790608
First received: November 12, 2008
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790608

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

No publications provided

Responsible Party: Nitric BioTherapeutics, Inc
ClinicalTrials.gov 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
Ulcer
Skin Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Pathologic Processes
Methicillin
Nitric Oxide
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
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 April 22, 2014