Microbiologic Response With Linezolid And Vancomycin In Ventilator-Associated Pneumonia Due To Methicillin Resistant Staphylococcus Aureus

Pfizer

Status and phase

Completed

Phase 4

Conditions

Pneumonia, Ventilator-Associated

Treatments

Drug: Vancomycin

Drug: Linezolid

Study type

Interventional

Funder types

Industry

Identifiers

NCT00572559

766-INF-0026-126

A5951069

Details and patient eligibility

About

Ventilator-associated pneumonia (VAP) is a commonplace complication of intensive care patients ventilated for longer than 48 hours. Methicillin-resistant Staphylococcus aureus (MRSA) is the cause of late onset VAP in up to about 30% of cases in US hospitals. Ineffective treatment of MRSA VAP clearly leads to prolonged mechanical ventilation and is probably associated with higher mortality. The purpose of this protocol is to directly compare linezolid and vancomycin specifically for MRSA VAP.

Enrollment

149 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

The patient must have or be suspected of having a ventilator-associated pneumonia (VAP) due to MRSA.
Patient must be hospitalized for at least 5 days, must be ventilator-dependent ≥ 48 hours prior to screen/baseline, and anticipated to remain on the ventilator for 72 hours after enrollment so follow-up BAL can be performed.
Clinical picture compatible with pneumonia (acquired during ventilation)
Chest X Ray at baseline/screen or within 24 hours of initiation of therapy must be consistent with diagnosis of pneumonia

Exclusion criteria

Hypersensitivity to linezolid, vancomycin, or one of the excipients in any of these drug formulations.
Infections due to gram-positive organisms known to be resistant to either of the study drugs.
Any antibiotic used in the treatment of MRSA, such as vancomycin, TMP/SMX, rifampin, or linezolid, for more than 48 hours prior to patient's enrollment into the study.
Patients with neutropenia, AIDS, lymphoma or anticipated chemotherapy.
Patients who have long-term tracheostomy (for more than 60 days). Acute tracheostomy patients are allowed.