| 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 |
| |
| |
| |
| 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 |
|
|
| 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 |