Phase 3 studies of ceftaroline for the treatment of community-acquired pneumonia (CAP)

Forest Laboratories presented data from its two Phase 3 studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients. These randomized, double-blind, multicenter studies (FOCUS 1 and FOCUS 2) compared clinical outcomes following treatment with ceftaroline versus ceftriaxone in hospitalized adult patients with moderate to severe CAP. The combined results of FOCUS 1 and FOCUS 2 demonstrated a clinical cure rate of 84.3% for ceftaroline and 77.7% for ceftriaxone in the integrated clinically evaluable (CE) patient population. The overall microbiological response rate in the microbiologically evaluable (ME) population was 87% for ceftaroline and 81% for ceftriaxone, and in the microbiological modified intent-to-treat (MITT) population it was 84.8% for ceftaroline and 80.4% for ceftriaxone.

Ceftaroline is a bactericidal, injectable, broad-spectrum cephalosporin being developed for the treatment of complicated skin and skin structure infections (cSSSI) and CAP which include gram-positive pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant S. pneumoniae (MDRSP), as well as common gram-negative organisms.

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