Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-27 @ 5:07 PM
Study NCT ID:
NCT01561469
Status:
COMPLETED
Last Update Posted:
2014-07-10
First Post:
2012-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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'}, {'id': 'D014640', 'term': 'Vancomycin'}], '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'}, {'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': "Prioritization of endpoints as primary or secondary was not specified in protocol and was based on study team's inputs."}}, 'adverseEventsModule': {'description': 'Due to retrospective nature of the study, adverse events data was not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '14 days after diagnosis with VAP or hospital discharge, whichever occurred first', 'description': 'Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the eligibility criteria for this study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Microbiological Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}], 'classes': [{'title': 'Superinfections', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'Colonization', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.00', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Analysis for superinfections category reported.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.759', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Analysis for colonization category reported.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '28 days after diagnosis of VAP', 'description': 'Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the eligibility criteria for this study.'}, {'type': 'SECONDARY', 'title': 'Duration of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '28'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '11', 'upperLimit': '25.5'}]}]}], 'analyses': [{'pValue': '0.773', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 days after diagnosis of VAP', 'description': 'Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the eligibility criteria for this study.'}, {'type': 'SECONDARY', 'title': 'Duration of Intensive Care Unit (ICU) Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '22'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '19.5'}]}]}], 'analyses': [{'pValue': '0.823', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 days after diagnosis of VAP', 'description': 'Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the eligibility criteria for this study.'}, {'type': 'SECONDARY', 'title': 'Duration of Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '24'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '24'}]}]}], 'analyses': [{'pValue': '0.276', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 28 days after diagnosis of VAP', 'description': 'Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the eligibility criteria for this study.'}, {'type': 'SECONDARY', 'title': 'Duration of Antimicrobial Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'spread': '4', 'groupId': 'OG000'}, {'value': '11', 'spread': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.512', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Up to 28 days after diagnosis of VAP', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who met the eligibility criteria for this study.'}, {'type': 'SECONDARY', 'title': 'Number of Antibiotic Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}], 'timeFrame': 'Up to 28 days after diagnosis of VAP', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed for this outcome because other reported measures (that is, duration of antimicrobial treatment, duration of mechanical ventilation, duration of ICU stay, duration of hospital stay) were considered to represent a more strict and useful reflection of resource utilization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'FG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Linezolid', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'BG001', 'title': 'Vancomycin', 'description': 'Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia \\[HAP\\]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '68'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '40', 'upperLimit': '66'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '45.75', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '112', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis population included all participants who met the eligibility criteria for this study.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-09', 'studyFirstSubmitDate': '2012-03-21', 'resultsFirstSubmitDate': '2014-06-09', 'studyFirstSubmitQcDate': '2012-03-21', 'lastUpdatePostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-09', 'studyFirstPostDateStruct': {'date': '2012-03-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Success', 'timeFrame': '14 days after diagnosis with VAP or hospital discharge, whichever occurred first', 'description': 'Clinical success was assessed as number of participants cured or improved. Cure = complete resolution of signs and symptoms of pneumonia; Improvement = partial resolution of signs and symptoms of pneumonia.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Microbiological Outcome', 'timeFrame': '28 days after diagnosis of VAP', 'description': 'Microbiological outcome was defined as superinfections (infections diagnosed within 72 hours of the diagnosis of HAP and until day 28) and colonization (positive cultures with a multi-drug resistant organism).'}, {'measure': 'Duration of Hospital Stay', 'timeFrame': 'Up to 28 days after diagnosis of VAP', 'description': 'Duration of hospital stay was assessed as number of days from VAP diagnosis to discharge from the hospital.'}, {'measure': 'Duration of Intensive Care Unit (ICU) Stay', 'timeFrame': 'Up to 28 days after diagnosis of VAP', 'description': 'Duration of ICU stay was assessed as number of days from VAP diagnosis to discharge from the ICU.'}, {'measure': 'Duration of Mechanical Ventilation', 'timeFrame': 'Up to 28 days after diagnosis of VAP', 'description': 'Duration of mechanical ventilation was assessed as number of days from VAP diagnosis to extubation or to discharge if not extubated.'}, {'measure': 'Duration of Antimicrobial Treatment', 'timeFrame': 'Up to 28 days after diagnosis of VAP'}, {'measure': 'Number of Antibiotic Free Days', 'timeFrame': 'Up to 28 days after diagnosis of VAP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Linezolid', 'Vancomycin', 'Ventilator-Associated Pneumonia', 'Respiratory Tract Infections'], 'conditions': ['Methicillin-Resistant Staphylococcus Aureus (MRSA)', 'Hospital-Acquired Pneumonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951168&StudyName=Evaluation%20of%20Patients%20with%20Methicillin-Resistant%20Staphylococcus%20aureus%20Hospital-Acquired%20Pneumonia%20Treated%20with%20Linezolid%20or%20Vancomycin', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to review the local management of patients with methicillin-resistant Staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference exists among these antimicrobials in regard to clinical and economic outcomes.', 'detailedDescription': 'Non-randomized, retrospective, observational study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This non-interventional study will retrospectively evaluate patients with documented MRSA hospital-acquired including ventilator-associated pneumonia treated with linezolid or vancomycin with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients will be enrolled in the study if they fulfill the following three inclusion criteria:\n\n1. Protocol criteria for HAP/VAP: Criteria for making a correct diagnosis of HAP will be met if the patient develops a new or progressive pulmonary infiltrate associated with at least two of the following: new or increased respiratory symptomatology (cough, sputum or tracheal secretions, shortness of breath), fever or hypothermia, leukocytosis, left shift, or leukopenia, or deterioration of pulmonary function.\n2. Isolation of MRSA from a respiratory sample or blood culture within 48 hours of the diagnosis of HAP/VAP\n3. Treatment of MRSA HAP/VAP with either vancomycin or linezolid with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm\n\nExclusion Criteria:\n\nPatients not meeting enrollment criteria.'}, 'identificationModule': {'nctId': 'NCT01561469', 'briefTitle': 'Evaluation of Patients With Methicillin-Resistant Staphylococcus Aureus Hospital-Acquired Pneumonia Treated With Linezolid or Vancomycin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Multicenter, Retrospective, Observational Study to Evaluate Clinical and Economic Outcomes of Patients With MRSA Hospital-Acquired Pneumonia Treated With Linezolid Or Vancomycin', 'orgStudyIdInfo': {'id': 'A5951168'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Linezolid observational cohort', 'interventionNames': ['Drug: Linezolid']}, {'label': 'Vancomycin observational cohort', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'Linezolid', 'type': 'DRUG', 'otherNames': ['Zyvox'], 'description': 'Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.', 'armGroupLabels': ['Linezolid observational cohort']}, {'name': 'Vancomycin', 'type': 'DRUG', 'otherNames': ['Vancocin'], 'description': 'Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.', 'armGroupLabels': ['Vancomycin observational cohort']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Louisville', 'class': 'OTHER'}, {'name': 'Henry Ford Hospital', 'class': 'OTHER'}, {'name': 'Summa Health System', 'class': 'OTHER'}, {'name': 'Sparrow Health System', 'class': 'OTHER'}, {'name': 'Jackson Health System', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}