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

November 28, 2011 updated by: Nitric BioTherapeutics, Inc

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XN
        • Department of Wound Healing, Cardiff University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in bioburden (specifically MRSA)as assessed via quantitative cultures.
Time Frame: 10 Days
10 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment
Time Frame: 10 Days
10 Days
Incidence of adverse events
Time Frame: 10 Days
10 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nitric BioTherapeutics, Inc

Investigators

  • Principal Investigator: Keith Harding, MB ChB, MRGCP, FRCS, Department of Wound Healing, Cardiff University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 28, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTP 5
  • EudraCT 2008-001287-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Skin Ulcers

Clinical Trials on Nitric Oxide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe