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TerminatedNCT00790608Updated Nov 29, 2011

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

A Phase 2 interventional study of Nitric Oxide in Skin Ulcers and Methicillin-resistant Staphylococcus Aureus Infection, sponsored by Nitric BioTherapeutics, Inc. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-29.

Sponsored by Nitric BioTherapeutics, Inc · Phase 2, Interventional, and Treatment

Why this study was terminated
Limited recruitment
Phase
Phase 2
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Skin Ulcers
  • Methicillin-resistant Staphylococcus Aureus Infection
03

In context

Staphylococcal Infections

273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.

This study's enrollment of 8 is below the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.

Browse Staphylococcal Infections studies →

Lead sponsor

Nitric BioTherapeutics, Inc is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Interventions

  • DrugNitric Oxide

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

06

What researchers measure

Primary outcomes

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

    Time frame: 10 Days

Secondary outcomes

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

    Time frame: 10 Days

  2. Incidence of adverse events

    Time frame: 10 Days

07

Study locations

1 site
  • Department of Wound Healing, Cardiff University
    Cardiff, CF14 4XN, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00790608
Lead sponsor
Nitric BioTherapeutics, Inc
Responsible party
Sponsor
First posted
Nov 13, 2008
Start date
Jan 2009
Primary completion
May 2009
Completion
Aug 2011
Last update
Nov 29, 2011

Study contacts

Keith Harding, MB ChB, MRGCP, FRCS
principal investigator · Department of Wound Healing, Cardiff University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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