Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT00771368
Status:
TERMINATED
Last Update Posted:
2012-01-19
First Post:
2008-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Bacteria in MRSA Positive Ulcers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007871', 'term': 'Leg Ulcer'}, {'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009569', 'term': 'Nitric Oxide'}], 'ancestors': [{'id': 'D026361', 'term': 'Reactive Nitrogen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'whyStopped': 'limited recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2008-10-10', 'studyFirstSubmitQcDate': '2008-10-10', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in bacteria', 'timeFrame': 'Post Treatment Day 3'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': '3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Leg Ulcer', 'Pressure Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if gaseous nitric oxide is effective in the treatement of bacteria in MRSA positive ulcers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Must have given written informed consent\n* Must be 19 years of age or over\n* Must have an ulcer or lesion in which the presence of MRSA has been positively identified but which is not clinically infected.\n* Must have an Ulcer / Lesion size not to extend beyond the inner borders of the wound cover\n\nExclusion Criteria:\n\n* Is a female who is pregnant, nursing, or of child bearing potential who is not using an adequate form of contraception (or abstinence)\n* Is \\< 19 years of age\n* Has a clinically infected ulcer\n* Has an Ulcer / Lesion that is currently treated or has been treated with a topical antimicrobial agent during 3 days prior to enrolment.\n* Has been using systemic antibiotics during 7 days prior to enrolment into this study.\n* Has an Ulcer / Lesion which is identified as malignant in origin (e.g., Marjolin's ulcer)\n* Has an Ulcer / Lesion size beyond the inner borders of the wound cover\n* Is septic or has other signs of an invasive infection\n* Has used any other investigational product within 30 days preceding study participation.\n* Suffers from a condition, which, in the opinion of the Investigator,would compromise his or her safety.\n* Suffers from a condition which, in the opinion of the Investigator, would compromise the quality of the data.\n* Has a known allergy to any of the products that are part of this protocol\n* 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.\n* Is using any of the prohibited concomitant medications or treatments"}, 'identificationModule': {'nctId': 'NCT00771368', 'briefTitle': 'Reduction of Bacteria in MRSA Positive Ulcers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nitric BioTherapeutics, Inc'}, 'officialTitle': 'A Clinical Trial on the Reduction of Bacteria (Including MRSA) in MRSA Positive Ulcers and Lesions', 'orgStudyIdInfo': {'id': 'CTP 7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nitric Oxide', 'description': 'gaseous nitric oxide delivered topically for 30 minutes', 'interventionNames': ['Drug: Nitric Oxide']}], 'interventions': [{'name': 'Nitric Oxide', 'type': 'DRUG', 'description': '1 % Gaseous Nitric Oxide, delivered for 30 minutes daily for 3 consecutive days', 'armGroupLabels': ['Nitric Oxide']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nitric BioTherapeutics, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'President & CEO', 'oldOrganization': 'Nitric BioTherapeutics, Inc.'}}}}