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

Primary Purpose

Skin Ulcers, Methicillin-resistant Staphylococcus Aureus Infection

Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Nitric Oxide
Sponsored by
Nitric BioTherapeutics, Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Ulcers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Wound Healing, Cardiff University

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment
Incidence of adverse events

Full Information

First Posted
November 12, 2008
Last Updated
November 28, 2011
Sponsor
Nitric BioTherapeutics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00790608
Brief Title
Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)
Official Title
A Phase II Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Limited recruitment
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nitric BioTherapeutics, Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Ulcers, Methicillin-resistant Staphylococcus Aureus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Intervention Description
Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days
Primary Outcome Measure Information:
Title
Change in bioburden (specifically MRSA)as assessed via quantitative cultures.
Time Frame
10 Days
Secondary Outcome Measure Information:
Title
Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment
Time Frame
10 Days
Title
Incidence of adverse events
Time Frame
10 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Harding, MB ChB, MRGCP, FRCS
Organizational Affiliation
Department of Wound Healing, Cardiff University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Wound Healing, Cardiff University
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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