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

Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819935
• Other study ID #: A5951163
• Status: Completed
• Phase: N/A
• First received: February 28, 2013
• Last updated: December 12, 2013
• Start date: December 2012
• Est. completion date: January 2013

Study information

• Verified date: December 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5271
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Pneumonia
• Staphylococcal Infections

Intervention

Drug:
• linezolid (Zyvox)
As prescribed-this is retrospective cohort of existing clinical data.
• vancomycin
As prescribed-this is retrospective cohort of existing clinical data.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

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