This article is more than 5 years old. Information may no longer be current.
Linezolid outperformed vancomycin for treatment of nosocomial pneumonia due to MRSA
Click Here to Manage Email Alerts
Linezolid had an end-of-study success rate that was more than 10% higher than vancomycin in patients with nosocomial or health care-associated pneumonia due to methicillin-resistant Staphylococcus aureus, according to findings presented at the 48th Annual Meeting of the Infectious Diseases Society of America.
Jean E. Chastre, MD, of the Reanimation Medicale, Pitie-Salpetriere Hospital in Paris, presented the results of the phase 4 randomized, double blind trial that was conducted in 156 centers worldwide, including 90 sites in the US.
Researchers compared the efficacy and safety of linezolid with vancomycin in nosocomial or health care-associated pneumonia due to proven MRSA.
There were 1,225 adult participants randomly assigned in a 1:1 ratio to IV linezolid 600 mg twice daily or vancomycin 15 mg/kg twice daily. The treatment period was 7 to 14 days. Patients were evaluated for safety and efficacy at the end of treatment and at study end (7 to 30 days after the end of treatment).
The researchers conducted three analyses: intention-to-treat (ITT); modified ITT (mITT), which involved patients with proven MRSA nosocomial pneumonia; and, per protocol, which included patients in the mITT group who met key protocol criteria.
Among 1,184 patients who were treated, 38% were evaluable in the mITT analysis and 29% were evaluable in the per-protocol group at the end of the study. The two groups were comparable regarding baseline characteristics and clinical parameters.
The mean per-protocol APACHE-II scores were 17.2 among patients receiving linezolid and 17.4 among patients receiving vancomycin. Sixty-seven percent of linezolid patients and 74% of vancomycin patients in the per-protocol analysis were ventilated.
Results indicated that 57.6% of patients in the linezolid group and 46.6% of patients in the vancomycin group achieved end-of-study success. This resulted in both non-inferiority (95% CI, 0.5%-21.6%) and statistical superiority (P=.042).
“This is an absolute difference of 11 percentage points,” Chastre said. “Based on our pre-specified plan, linezolid was not only non-inferior but superior to vancomycin.”
Chastre said that secondary endpoints were consistent with primary endpoint results. “We saw statistical superiority for success rates in several categories, including 83% for linezolid and 70% for vancomycin in the end-of-treatment per-protocol analysis. In the mITT group, it was 80% vs. 68% in favor of linezolid.”
Chastre JE. #154a [LB-49].
- Disclosure: Chastre reported being an investigator and scientific advisor, and receiving consulting fees and speaker honoraria from Pfizer.