Table 9.
FOCUS trials: clinical cure rates by study population at the test-of-cure visit
| Study population
|
||||
|---|---|---|---|---|
| CE | MITTE | ME | mMITTE | |
| FOCUS 1 (%) | ||||
| Ceftaroline | 86.6 | 83.8 | 89.9 | 88.0 |
| Ceftriaxone | 78.2 | 77.7 | 76.1 | 75.0 |
| Difference, % (95% CI) | 8.4 (1.4–15.4) | 6.2 (−0.2 to 12.6) | 13.8 (1.3–26.4) | 13.0 (0.7–25.2) |
| FOCUS 2 (%) | ||||
| Ceftaroline | 82.1 | 81.3 | 81.2 | 80.0 |
| Ceftriaxone | 77.2 | 75.5 | 75.0 | 75.0 |
| Difference, % (95% CI) | 4.9 (−2.5 to 12.5) | 5.9 (−1.0 to 12.7) | 6.2 (−6.7 to 19.2) | 5.0 (−7.4 to 17.4) |
| Integrated FOCUS (%) | ||||
| Ceftaroline | 84.3 | 82.6 | 85.1 | 83.6 |
| Ceftriaxone | 77.7 | 76.6 | 75.5 | 75.0 |
| Difference, % (95% CI) | 6.7 (1.6–11.8) | 6.0 (1.4–10.7) | 9.7 (0.7–18.8) | 8.7 (−0.0 to 17.4) |
Notes: File JM Jr, Low DE, Eckburg PB, et al. FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011;66(Suppl 3):iii19–iii32, by permission of Oxford University Press.68 Low DE, File TM Jr, Eckburg PB, et al. FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia. J Antimicrob Chemother. 2011;66(Suppl 3):iii33–iii44, by permission of Oxford University Press.69 File TM Jr, Low DE, Eckburg PB, et al. Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia. Clin Infect Dis. 2010;51(12):1395–1405, by permission of Oxford University Press.70
Abbreviations: CI, confidence interval; CE, clinically evaluable; FOCUS, ceftaroline community-acquired pneumonia trial versus ceftriaxone; MITTE, modified intent-to-treat; ME, microbiologically evaluable; mMITTE, microbiological MITTE.