NCT00084266

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,225 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Methicillin Resistant Staphylococcus Aureus (MRSA)

Interventions

Type	Name	Description
DRUG	linezolid (Zyvox)	Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
DRUG	vancomycin	Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.

Timeline

• Start date: 2004-10-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2004-06-11
• Last updated: 2012-02-01
• Results posted: 2011-05-09

Locations

177 sites across 22 countries: United States, Argentina, Belgium, Brazil, Chile, Colombia, France, Germany, Greece, Hong Kong, Malaysia, Mexico, Poland, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom