Table 3.
Summary of clinical cure rate at the test-of-cure visit in the co-primary analysis populations, FOCUS and CANVAS trials [12–15, 44, 47]
| Trial | MITTE | CE | ||||
|---|---|---|---|---|---|---|
| FOCUSa | Clinical cure % (no. of cured/total no.) | Differenceb (95% CI) | Clinical cure % (no. of cured/total no.) | Differenceb (95% CI) | ||
| Ceftaroline | Ceftriaxone | Ceftaroline | Ceftriaxone | |||
| 1 | 83.8 (244/291) | 77.7 (233/300) | 6.2 (−0.2, 12.6) | 86.6 (194/224) | 78.2 (183/234) | 8.4 (1.4, 15.4) |
| 2 | 81.3 (235/289) | 75.5 (206/273) | 5.9 (−1.0, 12.7) | 82.1 (193/235) | 77.2 (166/215) | 4.9 (−2.5, 12.5) |
| 1 and 2 | 82.6 (479/580) | 76.6 (439/573) | 6.0c (1.4, 10.7) | 84.3 (387/459) | 77.7 (349/449) | 6.7c (1.6, 11.8) |
| Trial | MITT | CE | ||||
|---|---|---|---|---|---|---|
| CANVASa | Clinical cure % (no. cured/total no.) | Differenceb (95% CI) | Clinical cure % (no. cured/total no.) | Differenceb (95% CI) | ||
| Ceftaroline | Vanc/Az | Ceftaroline | Vanc/Az | |||
| 1 | 86.6 (304/351) | 85.6 (297/347) | 1.0 (−4.2, 6.2) | 91.1 (288/316) | 93.3 (280/300) | −2.2 (−6.6, 2.1) |
| 2 | 85.1 (291/342) | 85.5 (289/338) | −0.4 (−5.8, 5.0) | 92.2 (271/294)) | 92.1 (269/292) | 0.1 (−4.4, 4.5) |
| 1 and 2 | 85.9 (595/693) | 85.5 (586/685) | 0.3 (−3.4, 4.0) | 91.6 (559/610) | 92.7 (549/592) | −1.1 (−4.2, 2.0) |
CE clinical efficacy population, CI confidence interval, MITT modified intent-to-treat population, MITTE modified intent-to-treat efficacy population, Vanc/Az vancomycin plus aztreonam combination
aNon-inferiority margin was set at −10% for both FOCUS and CANVAS trials
bTreatment difference: cure rate ceftaroline − cure rate comparator group
cWeighted treatment difference