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


Tracking Information

Start Date  ICMJEOctober 2004
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 4, 2009)		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 ]
Original Primary Outcome Measures  ICMJE 
 (submitted: September 8, 2005)		To compare the clinical efficacy of linezolid to vancomycin in the treatment of nosocomial pneumonia due to MRSA in hospitalized adults
Change HistoryComplete list of historical versions of study NCT00084266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 4, 2009)		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 ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: September 8, 2005)		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

Descriptive Information

Brief Title  ICMJENosocomial Pneumonia With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official Title  ICMJELinezolid in the Treatment of Subjects With Nosocomial Pneumonia Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
Brief Summary

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.

Detailed Description 
Study PhasePhase IV
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEPneumonia, Staphylococcal
Intervention  ICMJE
  • Drug: linezolid
    Subjects to receive either linezolid 600 mg IV or PO q 12 h for 7-14d, except in the presence of bacteremia, when it can continue for up to 21d.
  • Drug: vancomycin
    Subjects to receive vancomycin 15mg/kg IV q12h (adjusted for renal function) for 7-14d, except in the presence of bacteremia, when it can continue for up to 21 d.
Study Arms / Comparison Groups
  • 1: Experimental
    Subjects receiving linezolid for the treatment phase of the study
    Intervention: Drug: linezolid
  • 2: Active Comparator
    Subjects receiving vancomycin for the treatment phase of the study
    Intervention: Drug: vancomycin

Recruitment Information

Estimated Enrollment  ICMJE1200
Estimated Completion DateJune 2010
Estimated Primary Completion DateJune 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited 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

Administrative Information

NCT ID  ICMJENCT00084266
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study ID Numbers  ICMJEA5951001
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer