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

November 12, 2008
November 28, 2011
January 2009
May 2009   (final data collection date for primary outcome measure)
Change in bioburden (specifically MRSA)as assessed via quantitative cultures. [ Time Frame: 10 Days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00790608 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)
A Phase II Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Skin Ulcers
  • Methicillin-resistant Staphylococcus Aureus Infection
Drug: Nitric Oxide
Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
August 2011
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00790608
CTP 5, EudraCT 2008-001287-36
No
Nitric BioTherapeutics, Inc
Nitric BioTherapeutics, Inc
Not Provided
Principal Investigator: Keith Harding, MB ChB, MRGCP, FRCS Department of Wound Healing, Cardiff University
Nitric BioTherapeutics, Inc
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP