Completed

ZEPHYRLinezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus

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What is being tested

linezolid (Zyvox)

+ vancomycin

Drug
Who is being recruted

Healthcare-Associated Pneumonia+11

+ Bacterial Infections and Mycoses

+ Bacterial Infections

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: October 2004
See protocol details

Summary

Principal SponsorPfizer
Last updated: January 13, 2026
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Study start date: October 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleLinezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus 
NCT00084266
Principal SponsorPfizer
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1225 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Healthcare-Associated PneumoniaBacterial Infections and MycosesBacterial InfectionsCross InfectionIatrogenic DiseaseInfectionsLung DiseasesPathologic ProcessesPneumoniaRespiratory Tract DiseasesRespiratory Tract InfectionsStaphylococcal InfectionsGram-Positive Bacterial InfectionsDisease Attributes

Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Subjects receiving linezolid for the treatment phase of the study

Group II

Active Comparator
Subjects receiving vancomycin for the treatment phase of the study

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 177 locations

Suspended

Pfizer Investigational Site

Birmingham, United StatesSee the location
Suspended

Pfizer Investigational Site

Birmingham, United States
Suspended

Pfizer Investigational Site

Birmingham, United States
Suspended

Pfizer Investigational Site

Huntsville, United States
Completed177 Study Centers