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

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

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

Conditions
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Pneumonia

Intervention / Treatment
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* Drug: linezolid (Zyvox)
* Drug: vancomycin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| linezolid (Zyvox)<br> | Drug: linezolid (Zyvox)<br>* As prescribed-this is retrospective cohort of existing clinical data.<br>|
| Vancomycin<br> | Drug: vancomycin<br>* As prescribed-this is retrospective cohort of existing clinical data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRSA. pneumonia, outcomes