After seeing the results of a randomized, controlled, double-blind, multinational, multi-center trial where 390 subjects got either Zevtera (192) or daptomycin plus optional aztreonam [the comparator] (198), the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for adults with Staphylococcus aureus bloodstream infections (bacteremia, adults with acute bacterial skin and skin structure infections, and pediatric patients three months and older with community-acquired bacterial pneumonia.
For bacteremia, 69.8 percent who received Zevtera achieved overall success compared to the current treatment at 68.7 percent.
For adults with acute bacterial skin and skin structure infections, Zevtera led to 91.3 percent early clinical response compared to 88.1 percent who received the daptomycin plus aztreonam.
For community-acquired bacterial pneumonia, the researchers randomly assigned 638 adults hospitalized with CABP and requiring IV antibacterial treatment for at least 3 days to receive either Zevtera (314) or ceftriaxone with optional linezolid (324). Of the subjects who received Zevtera, 76.4 percent achieved clinical cure rates at test-of-cure visits compared to 79.3 percent who received the comparator. Another trial included 138 pediatric patients.
Zevtera is a product of Basilea Pharmaceutica International Ltd.
