Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia
Clinical Outcomes Among a National Veterans Affairs Methicillin Resistant Staphylococcus Aureus (MRSA) Pneumonia Cohort Treated With Linezolid Or Vancomycin
1 other identifier
observational
5,271
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 28, 2013
CompletedFirst Posted
Study publicly available on registry
March 28, 2013
CompletedResults Posted
Study results publicly available
January 30, 2014
CompletedJanuary 30, 2014
December 1, 2013
1 month
February 28, 2013
December 12, 2013
December 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to 30-day Mortality
Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Secondary Outcomes (7)
Time to Therapy Change
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Discharge From the Hospital
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Transfer Out From the Intensive Care Unit (ICU)
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to Intubation
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
Time to 30-day Re-admission
Baseline (1 January 2001) up to 3559 Days (30 September 2010)
- +2 more secondary outcomes
Study Arms (2)
linezolid (Zyvox)
Vancomycin
Interventions
As prescribed-this is retrospective cohort of existing clinical data.
Eligibility Criteria
National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010
You may qualify if:
- MRSA and pneumonia cases by ICD-9 code identification.
- Diagnosis included during inpatient stay.
- Treatment initiation in hospital.
You may not qualify if:
- Death of discharge within 3 days of treatment initiation.
- Exposure to other treatments with MRSA activity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Results for 'time to intubation' was reported and not 'time to extubation' due to change in planned analysis.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2013
First Posted
March 28, 2013
Study Start
December 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
January 30, 2014
Results First Posted
January 30, 2014
Record last verified: 2013-12