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

NCT00790608 | Terminated Phase 2

• 2 other identifiers: CTP 5EudraCT 2008-001287-36
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Ulcers; Methicillin-resistant Staphylococcus Aureus Infection

Outcome Measures

Primary Outcomes (1)

• Change in bioburden (specifically MRSA)as assessed via quantitative cultures.

  10 Days

Secondary Outcomes (2)

• Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment

  10 Days

• Incidence of adverse events

  10 Days

Interventions

Nitric Oxide DRUG

Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nitric BioTherapeutics, Inc: lead

Study Sites (1)

Department of Wound Healing, Cardiff University

Cardiff, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Skin Ulcer

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• Keith Harding, MB ChB, MRGCP, FRCS

  Department of Wound Healing, Cardiff University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2008
• First Posted: November 13, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2011
• Last Updated: November 29, 2011

Record last verified: 2011-11

Locations

GB (1)