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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Methicillin Resistant Staphylococcus Aureus (MRSA)

Treatments

Drug: linezolid (Zyvox)

Drug: vancomycin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00084266

A5951001

Details and patient eligibility

About

To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (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.

Enrollment

1,225 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.