Clinical Outcomes of Methicillin Resistant Staphylococcus Aureus (MRSA) Hospital-Based Pneumonia

Completed

• Conditions: Pneumonia
• Interventions: Drug: linezolid (Zyvox); Drug: vancomycin

• Registration Number: NCT01819935
• Lead Sponsor: Pfizer

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 Timeline

• Study Start: 2012-12
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-02-28
• Study First Submitted QC: 2013-03-22
• Study First Posted: 2013-03-28
• Status Verified: 2013-12
• Results First Submitted: 2013-12-12
• Results First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Results First Posted: 2014-01-30
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5271

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
linezolid (Zyvox)	linezolid (Zyvox)	-
Vancomycin	vancomycin	-

Primary Outcome Measures

Name	Time	Method
Time to 30-day Mortality	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 Outcome Measures

Name	Time	Method
Time to Therapy Change	Baseline (1 January 2001) up to 3559 Days (30 September 2010)	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.
Time to Discharge From the Hospital	Baseline (1 January 2001) up to 3559 Days (30 September 2010)	Time to discharge from hospital was calculated from initiation of therapy (index date) to hospital discharge (event date).
Time to Transfer Out From the Intensive Care Unit (ICU)	Baseline (1 January 2001) up to 3559 Days (30 September 2010)	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.
Time to Intubation	Baseline (1 January 2001) up to 3559 Days (30 September 2010)	Time to intubation was calculated from the initiation of therapy (index date) to intubation (event date).
Time to 30-day Re-admission	Baseline (1 January 2001) up to 3559 Days (30 September 2010)	Time to readmission to any veterans affairs hospital facility within 30 days after hospital discharge was reported.
Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection	Baseline (1 January 2001) up to 3559 Days (30 September 2010)	Time to MRSA re-infection was defined as readmission with MRSA infection to any veterans affairs hospital facility within 30 days after hospital discharge.
Clinical Success	Baseline (1 January 2001) up to 3559 Days (30 September 2010)	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.