Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT00150332
Status:
COMPLETED
Last Update Posted:
2011-05-10
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2006-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-09', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2011-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resolution of infection at the time of completion of therapy'}], 'secondaryOutcomes': [{'measure': 'Adverse events'}]}, 'conditionsModule': {'conditions': ['Infections, Nosocomial']}, 'descriptionModule': {'briefSummary': 'Use of linezolid in patients with methicillin-resistant Staphylococcus aureus infections in Japan'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infection due to methicillin-resistant Staphylococcus aureus\n\nExclusion Criteria:\n\n* hypersensitivity to linezolid'}, 'identificationModule': {'nctId': 'NCT00150332', 'briefTitle': 'Linezolid for the Treatment of Infections Caused by Methicillin Resistant Staphylococcus Aureus in Japan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Linezolid (PNU-10766/PNU10766SS) in the Treatment of MRSA Infections in Patients Whose Conventional Therapy Has Failed, or Who Are Intolerant to Conventional Therapy; an Open-label, Multi-center Trial', 'orgStudyIdInfo': {'id': 'M12600067'}, 'secondaryIdInfos': [{'id': 'A5951054'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'linezolid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '296-0041', 'city': 'Kamogawa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.0969, 'lon': 140.1003}}, {'zip': '811-0213', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '813-0025', 'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '807-0051', 'city': 'Onga-gun', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'zip': '730-8619', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '734-8530', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '060-8648', 'city': 'Sappopro', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'zip': '006-8555', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '302-0118', 'city': 'Moriya', 'state': 'Ibaraki', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.93333, 'lon': 140.0}}, {'zip': '236-0051', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '615-8256', 'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '854-8501', 'city': 'Isahaya', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.84111, 'lon': 130.04306}}, {'zip': '852-8501', 'city': 'Nagasaki', 'state': 'Nagasaki', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.75, 'lon': 129.88333}}, {'zip': '701-0912', 'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'zip': '700-8505', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '703-8275', 'city': 'Okayama', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'zip': '565-8565', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '350-0495', 'city': 'Iruma-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Pfizer Investigational Site'}, {'zip': '187-0004', 'city': 'Kodaira', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.72603, 'lon': 139.48508}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer'}}}}