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Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)
This study is currently recruiting participants.
Study NCT00790608   Information provided by Nitric BioTherapeutics, Inc
First Received: November 12, 2008   Last Updated: July 10, 2009   History of Changes

November 12, 2008
July 10, 2009
January 2009
April 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
 
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.

 
Phase II
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Skin Ulcers
  • Methicillin-resistant Staphylococcus Aureus Infection
Drug: Nitric Oxide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
May 2009
April 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: Nicola Ivins + 44 (0) 2920746319 ivinsnm@Cardiff.ac.uk
United Kingdom
 
NCT00790608
Tanya Rhodes/Chief Technology Officer, Nitric BioTherapeutics
CTP 5, EudraCT 2008-001287-36
Nitric BioTherapeutics, Inc
 
Principal Investigator: Keith Harding, MB ChB, MRGCP, FRCS Department of Wound Healing, Cardiff University
Nitric BioTherapeutics, Inc
July 2009

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