Skin UlcersPhase 2NCT00790608
Clinical Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus (MRSA)
A Phase 2 study testing Nitric Oxide in people with Skin Ulcers and Methicillin-resistant Staphylococcus Aureus Infection, run by Nitric BioTherapeutics, Inc at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Ulcers, Methicillin-resistant Staphylococcus Aureus Infection
- What is being tested?
- Nitric Oxide
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2009to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Wound Healing, Cardiff University
Cardiff, CF14 4XN
About this study
Official title: 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.
- Being tested
- Nitric Oxide
- Medical subject headings
- Skin Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Gaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bioburden (specifically MRSA)as assessed via quantitative cultures.
Measured: 10 Days
Secondary outcomes (2)
Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment
Measured: 10 Days
Incidence of adverse events
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2009
- Study completionAug 2011
Why it stopped: Limited recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitric BioTherapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Harding, MB ChB, MRGCP, FRCS, Principal investigator, Department of Wound Healing, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790608
- Sponsor's protocol ID
- CTP 5
- Other IDs
- EudraCT 2008-001287-36
- Status last verified
- Nov 2011
- First submitted
- 12 Nov 2008
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial on the Reduction of Methicillin Resistant Staphylococcus Aureus in MRSA Positive Ulcers
- ClinicalTrials.gov ID
- NCT00790608
- Acronym / sponsor ID
- CTP 5
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited recruitment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Nitric BioTherapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideGaseous nitric oxide (1%), delivered for 30 minutes per day for 3 consecutive days | Drug | – |
Primary outcome
Change in bioburden (specifically MRSA)as assessed via quantitative cultures.
Time frame: 10 Days
2 secondary outcomes
Improvement in the condition of the ulcer as judged by comparative photography and independent clinical assessment
Time frame: 10 Days
Incidence of adverse events
Time frame: 10 Days
Results and safety
The study was stopped early (reason given: Limited recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Harding, MB ChB, MRGCP, FRCS principal investigator
Department of Wound Healing, Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide in people with Skin Ulcers and Methicillin-resistant Staphylococcus Aureus Infection, run by Nitric BioTherapeutics, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Limited recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bioburden (specifically MRSA)as assessed via quantitative cultures. (time frame: 10 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.