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Nosocomial Pneumonia With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) (ZEPHYR)
This study is currently recruiting participants.
Study NCT00084266   Information provided by Pfizer
First Received: June 9, 2004   Last Updated: August 13, 2009   History of Changes

June 9, 2004
August 13, 2009
October 2004
To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults [ Time Frame: up to 30 d after completion of treatment ] [ Designated as safety issue: No ]
To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults
Complete list of historical versions of study NCT00084266 on ClinicalTrials.gov Archive Site
To compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults [ Time Frame: up to 30 days after end of treatment ] [ Designated as safety issue: Yes ]
To compare the bacteriological efficacy and safety and tolerability of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults
 
Nosocomial Pneumonia With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Linezolid in the Treatment of Subjects With Nosocomial Pneumonia Proven to be Due to Methicillin-Resistant Staphylococcus Aureus

To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to MRSA in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.

 
Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Pneumonia, Staphylococcal
  • Drug: linezolid
  • Drug: vancomycin
  • Experimental: Subjects receiving linezolid for the treatment phase of the study
  • Active Comparator: Subjects receiving vancomycin for the treatment phase of the study
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1200
June 2010
June 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.
Both
18 Years and older
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Argentina,   Belgium,   Brazil,   Chile,   Colombia,   France,   Germany,   Greece,   Hong Kong,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   Singapore,   South Africa,   Spain,   Taiwan,   Turkey,   United Kingdom
 
 
NCT00084266
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
A5951001
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP