Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)
NCT ID: NCT00790608
Last Updated: 2011-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2009-01-31
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Nitric Oxide
Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days
Eligibility Criteria
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Inclusion Criteria
* 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 \< 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
18 Years
ALL
No
Sponsors
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Nitric BioTherapeutics, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Keith Harding, MB ChB, MRGCP, FRCS
Role: PRINCIPAL_INVESTIGATOR
Department of Wound Healing, Cardiff University
Locations
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Department of Wound Healing, Cardiff University
Cardiff, , United Kingdom
Countries
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Other Identifiers
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EudraCT 2008-001287-36
Identifier Type: -
Identifier Source: secondary_id
CTP 5
Identifier Type: -
Identifier Source: org_study_id