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Clinical Trials/NCT01819935
NCT01819935CompletedNot Applicable

Clinical Outcomes Among a National Veterans Affairs Methicillin Resistant Staphylococcus Aureus (MRSA) Pneumonia Cohort Treated With Linezolid Or Vancomycin

Pfizer0 sites5,271 target enrollmentStarted: December 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Pfizer
Enrollment
5,271
Primary Endpoint
Time to 30-day Mortality

Study Overview

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.

Detailed Description

All patients meeting inclusion/exclusion criteria from inpatient database from 1/1/02-9/30/10.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • MRSA and pneumonia cases by ICD-9 code identification.
  • Diagnosis included during inpatient stay.
  • Treatment initiation in hospital.

Exclusion Criteria

  • Death of discharge within 3 days of treatment initiation.
  • Exposure to other treatments with MRSA activity.

Arms & Interventions

linezolid (Zyvox)

Intervention: linezolid (Zyvox) (Drug)

Vancomycin

Intervention: vancomycin (Drug)

Outcomes

Primary Outcomes

Time to 30-day Mortality

Time Frame: Baseline (1 January 2001) up to 3559 Days (30 September 2010)

Time to death (all-cause mortality) occurring within 30 days of treatment initiation was reported. Mortality was assessed from admission vital status databases.

Secondary Outcomes

  • 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))
  • Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection(Baseline (1 January 2001) up to 3559 Days (30 September 2010))
  • Clinical Success(Baseline (1 January 2001) up to 3559 Days (30 September 2010))

Investigators

Sponsor
Pfizer
Sponsor Class
Industry
Responsible Party
Sponsor

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