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

Methicillin-resistant Staphylococcus Aureus Infection Clinical Trial

Official title:

A Phase II Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00790608
• Other study ID #: CTP 5
• Secondary ID: EudraCT 2008-001
• Status: Terminated
• Phase: Phase 2
• First received: November 12, 2008
• Last updated: November 28, 2011
• Start date: January 2009
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Nitric BioTherapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: August 2011
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus Infection
• Skin Ulcer
• Skin Ulcers
• Staphylococcal Infections

Intervention

Drug:
• Nitric Oxide
Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days

Locations

Country	Name	City	State
United Kingdom	Department of Wound Healing, Cardiff University	Cardiff

Sponsors (1)

Lead Sponsor	Collaborator
Nitric BioTherapeutics, Inc

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bioburden (specifically MRSA)as assessed via quantitative cultures.		10 Days	No
Secondary	Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment		10 Days	No
Secondary	Incidence of adverse events		10 Days	Yes