Reduction of Bacteria in MRSA Positive Ulcers

Pressure Ulcer Clinical Trial

Official title:

A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00771368
• Other study ID #: CTP 7
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: October 10, 2008
• Last updated: January 18, 2012
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: January 2012
• Source: Nitric BioTherapeutics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Must have given written informed consent

• Must be 19 years of age or over

• Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.

• Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover

Exclusion Criteria:

• Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)

• Is < 19 years of age

• Has a clinically infected ulcer

• Has an Ulcer / Lesion that is currently treated 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 / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer)

• Has an Ulcer / Lesion size beyond the inner borders of the wound cover

• Is septic or has other signs of an invasive infection

• Has used any other investigational product 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: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Pressure Ulcer
• Ulcer

Intervention

Drug:
• Nitric Oxide
1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Nitric BioTherapeutics, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in bacteria		Post Treatment Day 3	No
Secondary	Incidence of adverse events		3 days	Yes