Randomized, Doubled-Blinded, Multicenter Phase 3 Trials of the Efficacy and Safety

Background. Ceftaroline, the active form of ceftaroline fosamil, is a broad-spectrum cephalosporin with bac-tericidal activity against pathogens causing community-acquired pneumonia (CAP), including Streptococcus pneumoniae. Ceftaroline was evaluated for the treatment of CAP in 2 randomized, double-blind, multicenter trials: Ceftaroline Community Acquired Pneumonia Trial versus Ceftriaxone in Hospitalized Patients (FOCUS) 1 and FOCUS 2. Methods. Patients hospitalized (but not admitted to an intensive care unit) with Pneumonia Outcomes Research Team risk class III or IV CAP requiring intravenous therapy were randomized to ceftaroline 600 mg every 12 h or ceftriaxone 1 g every 24 h for 5–7 days. Patients in FOCUS 1 received 2 doses of oral clarithromycin 500 mg every 12 h on day 1. Results. In the individual trials, clinical cure rates in the clinically evaluable (CE) population for ceftaroline versus ceftriaxone were as follows: FOCUS 1, 86.6 % vs 78.2 % (difference, 8.4%; 95 % confidence interval [CI], 1.4%–15.4%); FOCUS 2, 82.1 % vs 77.2 % (difference, 4.9%; 95 % CI, 2.5 % to 12.5%). In the integrated analysis, 614 patients received ceftaroline and 614 received ceftriaxone. Of the CE patients treated with ceftaroline, 84.3% achieved clinical cure, compared with 77.7 % of ceftriaxone-treated patients (difference, 6.7%; 95 % CI, 1.6%– 11.8%). Clinical cure rates in the modified intent-to-treat efficacy population were 82.6 % versus 76.6 % for cef