The two globally conducted, multi-center, Phase III, randomized, double-blind comparative studies were designed to evaluate the efficacy and safety of ceftaroline compared to vancomycin plus aztreonam.
In both the studies, ceftaroline as monotherapy achieved the primary endpoint of non-inferiority versus the combination of vancomycin plus aztreonam. Ceftaroline treated patients had a clinical cure rate of 91.6% compared to a vancomycin plus aztreonam clinical cure rate of 92.7% at test-of-cure visit in the clinically evaluable population across both studies.
The studies were designed to a non-inferiority margin of 10% between ceftaroline and the comparator regimen. In addition, ceftaroline had a microbiological eradication rate of 92.4% compared to a vancomycin plus aztreonam rate of 93.6% for all pathogens when used as treatment for cSSSI.
The ceftaroline clinical cure rate was 93.1% in Staphylococcus aureus infections in the microbiologically evaluable population and 93.3% for MRSA infections. The study also indicated that ceftaroline was generally well-tolerated. The overall discontinuation rate for ceftaroline was 3% compared to 4.8% for vancomycin plus aztreonam.