Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-01-07 @ 5:11 AM
Study NCT ID:
NCT01564758
Status:
COMPLETED
Last Update Posted:
2012-08-06
First Post:
2012-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Marketing Surveillance Study on Linezolid
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Protocol did not indicate primary or secondary endpoints and all determination of primary or secondary endpoints were arbitrary.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Linezolid', 'description': "Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion.", 'otherNumAtRisk': 99, 'otherNumAffected': 5, 'seriousNumAtRisk': 99, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ill-defined disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': "Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion."}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to End of Treatment (EOT) (Day 10 up to 28)', 'description': 'Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the participants who received at least 1 dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': "Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion."}], 'classes': [{'title': 'Cure', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Improvement', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT (Day 10 up to 28)', 'description': 'Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy was evaluated for the safety analysis set which included all the participants who received at least 1 dose of study medication'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Linezolid', 'description': "Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Linezolid', 'description': "Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion."}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '18.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-27', 'studyFirstSubmitDate': '2012-03-26', 'resultsFirstSubmitDate': '2012-06-27', 'studyFirstSubmitQcDate': '2012-03-26', 'lastUpdatePostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-27', 'studyFirstPostDateStruct': {'date': '2012-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to End of Treatment (EOT) (Day 10 up to 28)', 'description': 'Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Clinical Response', 'timeFrame': 'EOT (Day 10 up to 28)', 'description': 'Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['non-interventional', 'non-comparative', 'open-label study', 'safety', 'Linezolid', 'gram positive infections', 'Filipino'], 'conditions': ['Gram-Positive Bacterial Infections']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951090&StudyName=Post%20Marketing%20Surveillance%20study%20on%20Linezolid%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.', 'detailedDescription': 'The subjects were identified after the physician decided to prescribed the drug to the subject.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult, Filipino patients diagnosed with gram positive infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium\n* Male or female, 18 years old and above\n\nExclusion Criteria:\n\n* Known hypersensitivity\n* Subjects diagnosed with pure gram-negative infection'}, 'identificationModule': {'nctId': 'NCT01564758', 'acronym': 'A5951090', 'briefTitle': 'Post Marketing Surveillance Study on Linezolid', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Post Marketing Surveillance on the Efficacy, Safety and Tolerability of Linezolid (Zyvox) in the Treatment of Gram Positive Infections', 'orgStudyIdInfo': {'id': 'A5951090'}, 'secondaryIdInfos': [{'id': 'GRAM POSITIVE INFECTIONS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Subjects that are diagnosed with gram positive infection', 'interventionNames': ['Drug: Linezolid']}], 'interventions': [{'name': 'Linezolid', 'type': 'DRUG', 'description': '1. Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days\n2. Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days\n3. Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}