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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Pfizer Investigational Site, San Juan 00921-3201, Puerto Rico
Pfizer Investigational Site, Phoenix, Arizona 85006, United States
Pfizer Investigational Site, Phoenix, Arizona 85012, United States
Pfizer Investigational Site, Palm Springs, California 92262, United States
Pfizer Investigational Site, Rancho Mirage, California 92270, United States
Pfizer Investigational Site, Redlands, California 92373, United States
Pfizer Investigational Site, Sacramento, California 95819, United States
Pfizer Investigational Site, Sacramento, California 95829, United States
Pfizer Investigational Site, Norwalk, Connecticut 06850, United States
Pfizer Investigational Site, Waterbury, Connecticut 06708, United States
Pfizer Investigational Site, Waterbury, Connecticut 06721, United States
Pfizer Investigational Site, Augusta, Georgia 30909, United States
Pfizer Investigational Site, Decatur, Georgia 30033, United States
Pfizer Investigational Site, North East Atlanta, Georgia 30308, United States
Pfizer Investigational Site, North East Atlanta, Georgia 30322, United States
Pfizer Investigational Site, North East Atlanta, Georgia 30329, United States
Pfizer Investigational Site, Ewa Beach, Hawaii 96706, United States
Pfizer Investigational Site, Chicago, Illinois 60612, United States
Pfizer Investigational Site, Peoria, Illinois 61603, United States
Pfizer Investigational Site, Peoria, Illinois 61636, United States
Pfizer Investigational Site, Peoria, Illinois 61637, United States
Pfizer Investigational Site, Lexington, Kentucky 40536, United States
Pfizer Investigational Site, Louisville, Kentucky 40206, United States
Pfizer Investigational Site, Bronx, New York 10467, United States
Pfizer Investigational Site, Buffalo, New York 14215, United States
Pfizer Investigational Site, Cortland Manor, New York 10567, United States
Pfizer Investigational Site, Jamaica, New York 11418, United States
Pfizer Investigational Site, Cincinnati, Ohio 45267-0559, United States
Pfizer Investigational Site, Memphis, Tennessee 38103, United States
Pfizer Investigational Site, Memphis, Tennessee 38104, United States
Pfizer Investigational Site, Memphis, Tennessee 38163, United States
Pfizer Investigational Site, Nashville, Tennessee 37212-3375, United States
Pfizer Investigational Site, Houston, Texas 77030, United States
Pfizer Investigational Site, Spokane, Washington 99204, United States
Pfizer Investigational Site, Spokane, Washington 99216, United States
Pfizer Investigational Site, Spokane, Washington 99220, United States
Pfizer Investigational Site, Morgantown, West Virginia 26505, United States