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Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35233 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Methicillin Resistant Staphylococcus Aureus (MRSA)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Hospitalized male and female subjects with clinically documented nosocomial pneumonia
proven to be due to methicillin-resistant staphylococcus aureus.

- Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the
diagnosis of pneumonia.

- Suitable sputum specimen defined as having less than 10 squamous epithelial cells and
greater or equal 25 leukocytes or have a culture taken by an invasive technique within
24 hours of study entry.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects who were treated with a previous antibiotic with MRSA activity (other than
linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment
failure (72 hours of treatment and not responding).

- Subjects with severe neutropenia (

- Subjects with hypersensitivity to oxazolidinones or vancomycin.

NCT00084266
Pfizer
Completed
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

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Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Methicillin Resistant Staphylococcus Aureus (MRSA)
  • Drug: linezolid (Zyvox)
    Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
    Other Name: Zyvox, linezolid
  • Drug: vancomycin
    Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
  • Experimental: 1
    Subjects receiving linezolid for the treatment phase of the study
    Intervention: Drug: linezolid (Zyvox)
  • Active Comparator: 2
    Subjects receiving vancomycin for the treatment phase of the study
    Intervention: Drug: vancomycin


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1225
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
  • Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
  • Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

Exclusion Criteria:

  • Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
  • Subjects with severe neutropenia (<500 cells/mm3)
  • Subjects with hypersensitivity to oxazolidinones or vancomycin.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Brazil,   Chile,   Colombia,   France,   Germany,   Greece,   Hong Kong,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Italy,   Singapore,   Venezuela
 
NCT00084266
A5951001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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