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Completed

NCT Number: NCT01819935

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

linezolid (Zyvox)

Drug

As prescribed-this is retrospective cohort of existing clinical data.

Vancomycin

Drug

As prescribed-this is retrospective cohort of existing clinical data.

Primary outcomes

  1. 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

  1. Time to Therapy Change

    Time frame: 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.

  2. Time to Discharge From the Hospital

    Time frame: 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).

  3. Time to Transfer Out From the Intensive Care Unit (ICU)

    Time frame: 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.

  4. Time to Intubation

    Time frame: 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).

  5. Time to 30-day Re-admission

    Time frame: 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.

  6. Time to 30-day Methicillin-Resistant Staphylococcus Aureus (MRSA) Re-infection

    Time frame: 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.

  7. Clinical Success

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 28, 2013
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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