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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
149
1 gram IV every 12 hours for 7 to 14 days
600 mg every 12 hours (intravenously \[IV\] for a minimum of the first 4 days followed by a switch to oral if tolerated by patient) for a total duration of 7 to 14 days
To assess early microbiologic response in patients with VAP due to MRSA based on semi-quantitative culture of bronchoscopic bronchoalveolar lavage (BAL) in patients treated with linezolid vs vancomycin.
Time frame: 72-96 hours
To compare duration of mechanical ventilation
Time frame: 0000
To compare post treatment tracheal colonization
Time frame: FU: 14 days after EOT +/- 2 days
To identify clinical correlates of infection based on microbiologic sampling as determined by original and modified CPIS (Clinical Pulmonary Infection Score)
Time frame: EOT: Day 14; FU: 14 days after EOT +/- 2 days
To compare the microbiological cure based on BAL specimens with the traditional criteria for microbiologic cure
Time frame: 72-96 hours
To compare mortality at End Of Treatment (EOT) and Follow up (FU); To compare clinical outcome at EOT and FU
Time frame: EOT: Day 14; FU: 14 days after EOT +/- 2 days
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Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Phoenix, Arizona, United States
Pfizer Investigational Site
Palm Springs, California, United States
Pfizer Investigational Site
Rancho Mirage, California, United States
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Redlands, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
Sacramento, California, United States
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Norwalk, Connecticut, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
Pfizer Investigational Site
Waterbury, Connecticut, United States
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