NCT01819935

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,271

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

January 30, 2014

Completed
Last Updated

January 30, 2014

Status Verified

December 1, 2013

Enrollment Period

1 month

First QC Date

February 28, 2013

Results QC Date

December 12, 2013

Last Update Submit

December 12, 2013

Conditions

Keywords

MRSA. pneumoniaoutcomes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Time to Therapy Change

    Baseline (1 January 2001) up to 3559 Days (30 September 2010)

  • Time to Discharge From the Hospital

    Baseline (1 January 2001) up to 3559 Days (30 September 2010)

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

    Baseline (1 January 2001) up to 3559 Days (30 September 2010)

  • Time to Intubation

    Baseline (1 January 2001) up to 3559 Days (30 September 2010)

  • Time to 30-day Re-admission

    Baseline (1 January 2001) up to 3559 Days (30 September 2010)

  • +2 more secondary outcomes

Study Arms (2)

linezolid (Zyvox)

Drug: linezolid (Zyvox)

Vancomycin

Drug: vancomycin

Interventions

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

linezolid (Zyvox)

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

Vancomycin

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • MRSA and pneumonia cases by ICD-9 code identification.
  • Diagnosis included during inpatient stay.
  • Treatment initiation in hospital.

You may not qualify if:

  • Death of discharge within 3 days of treatment initiation.
  • Exposure to other treatments with MRSA activity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pneumonia

Interventions

LinezolidVancomycin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsOxazolidinonesOxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and Proteins

Limitations and Caveats

Results for 'time to intubation' was reported and not 'time to extubation' due to change in planned analysis.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 28, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 30, 2014

Results First Posted

January 30, 2014

Record last verified: 2013-12