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

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.

Study Overview

• Status: Completed
• Conditions: Pneumonia
• Intervention / Treatment: Drug: linezolid (Zyvox); Drug: vancomycin

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 5271

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

National database of inpatient admissions between January 1, 2002 and Septmeber 30, 2010

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
linezolid (Zyvox)	Drug: linezolid (Zyvox); As prescribed-this is retrospective cohort of existing clinical data.
Vancomycin	Drug: vancomycin; As prescribed-this is retrospective cohort of existing clinical data.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 28, 2013
• First Submitted That Met QC Criteria: March 22, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): January 30, 2014
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: outcomes; MRSA. pneumonia
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Vancomycin; Linezolid
• Other Study ID Numbers: A5951163