Table 3.
Human Clinical Studies on the Efficacy of Ceftaroline
| Study Reference | Study Type | Infection | Sample | Antibiotics | Clinical Response | Microbiologic Response | Miscellaneous |
|---|---|---|---|---|---|---|---|
| CANVAS I [63] | Phase III Randomized Double-blind Multicenter Multinational noninferior |
SSTI | 702 | Ceftaroline (600 mg IV bid) Versus Vancomycin 1g IV bid +/− Aztreonam 1g IV bid (5–14 days) |
91.1%, (288/316) Versus 93.3%, (280/300) 95% CI: −2.2 (−6.6, 2.1) |
92.2% (225/244) Versus 94.7% (215/227) 95% CI −2.5 (−7.2, 2.1) |
MRSA 95.1% (78/82) for Ceftaroline 95.2% (59/62) for Vancomycin plus Aztreonam |
| CANVAS II [64] | Phase III Randomized Double-blind Multicenter noninferior |
SSTI | 694 | Ceftaroline (600 mg IV bid) Versus Vancomycin 1g IV bid +/− Aztreonam 1g IV bid (5–14 days) |
92.2%, (271/294) Versus 92.1%, 269/292; 95% CI: (−4.4, 4.5) |
93.9% (170/181) Versus 94.4% (168/178) −2.1% 95% CI (−6.9, 2.5) |
ME: MRSA 96.6% (56/58) for Ceftaroline 94.2% (49/52) for Vancomycin plus Aztreonam |
| Pooled CANVAS [62] | Phase III Randomized Double-blind Multicenter noninferior |
SSTI | 1378 | Ceftaroline (600 mg IV bid) Versus Vancomycin 1g IV bid +/− Aztreonam 1g IV bid (5–14 days) |
91.6% 92.7% | 92.3% 93.7% | Ceftaroline inferior to comparator for Gram-negative organisms such as Pseudomonas spp. |
| FOCUS 1 [66,67] | Phase III Randomized Double-blind Multicenter |
CAP PORT III/IV Hospitalized No ICU |
606 | Ceftaroline (600 mg IV q12) Versus Ceftriaxone (1 g IV daily) 5–7 days |
86.6% (194/224) Versus 78.2% (183/234) Difference: 8.4%, 95% CI (1.4%–15.4%) |
89.9% (62/69) Versus 76.1% (54/71) Difference: 13.8%, 95% CI (1.3–26.4) |
|
| FOCUS 2 [66,67] | Phase III Randomized Double-blind Multicenter |
CAP PORT III/IV Hospitalized No ICU |
562 | Ceftaroline (600 mg IV q12) Versus Ceftriaxone (1 g IV daily) 5–7 days |
82.1% 193/235 Versus 77.2% 166/215 Difference: 4.9%, 95% CI (−2.5%–12.5%) |
81.2% 69/85 Versus 75% 57/76 Difference: 6.2%, 95% CI (−6.7 – 19.2%) |
|
| Pooled FOCUS [66,67] | Phase III Randomized Double-blind Multicenter |
CAP PORT III/IV Hospitalized No ICU |
1228 | Ceftaroline (600 mg IV q12) Versus Ceftriaxone (1 g IV daily) 5–7 days |
84.3% 77.7% Difference: 6.7%, 95% CI (1.6%–11.8%) |
87.0% 81.0% Difference: 6.1%, 95% CI (−2.3% to 14.6%) |
Clinical response rates were 86% vs. 69% for all S. pneumoniae and 100% vs. 22% for MDRSP favouring ceftaroline |