Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01819935
Status:
COMPLETED
Last Update Posted:
2014-01-30
First Post:
2013-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia
Sponsor:
Organization:
Raw JSON
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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': "Results for 'time to intubation' was reported and not 'time to extubation' due to change in planned analysis."}}, 'adverseEventsModule': {'description': 'This retrospective study used participants-level electronic health related databases (e-HRD), in which it was not possible to link (i.e. identify a potential association between) a particular product and medical event for any individual. Thus, adverse events (AEs) were not reportable as individual AE reports.', 'eventGroups': [{'id': 'EG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to 30-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '4943', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '30'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '30'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.93', 'ciLowerLimit': '0.72', 'ciUpperLimit': '1.20', 'groupDescription': 'Propensity Cox proportional hazards regression model was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.'}, {'type': 'SECONDARY', 'title': 'Time to Therapy Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '4943', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.75', 'ciLowerLimit': '0.53', 'ciUpperLimit': '1.05', 'groupDescription': 'Propensity Cox proportional hazards regression model was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). 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Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.'}, {'type': 'SECONDARY', 'title': 'Time to Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '4943', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '59'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '28'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.37', 'groupDescription': 'Propensity Cox proportional hazards regression model was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.'}, {'type': 'SECONDARY', 'title': 'Time to 30-day Re-admission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '4943', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '30'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '30'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.68', 'ciUpperLimit': '1.13', 'groupDescription': 'Propensity Cox proportional hazards regression model was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.'}, {'type': 'SECONDARY', 'title': 'Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'OG000'}, {'value': '4943', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '30'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '30'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.48', 'groupDescription': 'Propensity Cox proportional hazards regression model was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '3500', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.24', 'ciLowerLimit': '1.06', 'ciUpperLimit': '1.45', 'groupDescription': 'Propensity Cox proportional hazards regression model was used.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia. Here, "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.'}, {'id': 'FG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}, {'groupId': 'FG001', 'numSubjects': '4943'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '328'}, {'groupId': 'FG001', 'numSubjects': '4943'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '328', 'groupId': 'BG000'}, {'value': '4943', 'groupId': 'BG001'}, {'value': '5271', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Linezolid', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases - revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.'}, {'id': 'BG001', 'title': 'Vancomycin', 'description': 'Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '12.5', 'groupId': 'BG000'}, {'value': '69.1', 'spread': '12.7', 'groupId': 'BG001'}, {'value': '69.1', 'spread': '12.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '4844', 'groupId': 'BG001'}, {'value': '5167', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5271}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-12', 'studyFirstSubmitDate': '2013-02-28', 'resultsFirstSubmitDate': '2013-12-12', 'studyFirstSubmitQcDate': '2013-03-22', 'lastUpdatePostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-12', 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to 30-day Mortality', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.'}], 'secondaryOutcomes': [{'measure': 'Time to Therapy Change', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to therapy change was calculated from initiation of therapy (index date) to change in therapy (event date). Therapy change was defined as the discontinuation of linezolid or vancomycin and initiation of a different agent with activity against MRSA (clindamycin, daptomycin, doxycycline, linezolid, minocycline, tigecycline, trimethoprim/sulfamethoxazole, vancomycin). As such, therapy change included switching from linezolid to vancomycin, switching from vancomycin to linezolid, or switching from either linezolid or vancomycin to another anti-MRSA antibiotic.'}, {'measure': 'Time to Discharge From the Hospital', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).'}, {'measure': 'Time to Transfer Out From the Intensive Care Unit (ICU)', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to discharge from the ICU was calculated from the initiation of therapy (index date) to the time the participant was transferred out from ICU (event date). Transfer out of an ICU was assessed among those participants who had initiated linezolid or vancomycin therapy in the ICU.'}, {'measure': 'Time to Intubation', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).'}, {'measure': 'Time to 30-day Re-admission', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.'}, {'measure': 'Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.'}, {'measure': 'Clinical Success', 'timeFrame': 'Baseline (1 January 2001) up to 3559 Days (30 September 2010)', 'description': 'Clinical success, a composite outcome defined as discharge from the hospital or ICU by day 14 after treatment initiation, in the absence of death, therapy change, or intubation by day 14. Percentage of participants with clinical success was reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRSA. pneumonia', 'outcomes'], 'conditions': ['Pneumonia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5951163&StudyName=Clinical%20Outcomes%20of%20Methicillin%20Resistant%20Staphylococcus%20Aureus%20%28MRSA%29%20Hospital-Based%20Pneumonia', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this non-interventional, retrospective study of existing data is to evaluate clinical outcomes related to Methicillin-resistant Staphylococcus aureus hospital based pneumonia by treatment and among subpopulations.', 'detailedDescription': 'All patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MRSA and pneumonia cases by ICD-9 code identification.\n* Diagnosis included during inpatient stay.\n* Treatment initiation in hospital.\n\nExclusion Criteria:\n\n* Death of discharge within 3 days of treatment initiation.\n* Exposure to other treatments with MRSA activity.'}, 'identificationModule': {'nctId': 'NCT01819935', 'briefTitle': 'Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Clinical Outcomes Among a National Veterans Affairs Methicillin Resistant Staphylococcus Aureus (MRSA) Pneumonia Cohort Treated With Linezolid Or Vancomycin', 'orgStudyIdInfo': {'id': 'A5951163'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'linezolid (Zyvox)', 'interventionNames': ['Drug: linezolid (Zyvox)']}, {'label': 'Vancomycin', 'interventionNames': ['Drug: vancomycin']}], 'interventions': [{'name': 'linezolid (Zyvox)', 'type': 'DRUG', 'description': 'As prescribed-this is retrospective cohort of existing clinical data.', 'armGroupLabels': ['linezolid (Zyvox)']}, {'name': 'vancomycin', 'type': 'DRUG', 'description': 'As prescribed-this is retrospective cohort of existing clinical data.', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}