Pivotal Clinical Studies

Pivotal Phase III ZINFORO^® (ceftaroline fosamil) cSSTI studies
 

The efficacy and tolerability of ZINFORO^® (ceftaroline fosamil) monotherapy have been consistently demonstrated in 6 large, double-blind, Phase III, randomised controlled clinical trials – 3 involving adult patients with cSSTI and 3 in patients with CAP.^{1-4
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The safety and efficacy of ZINFORO^® (ceftaroline fosamil) has also been examined in 2 clinical studies involving paediatric patients with CAP and cSSTI.^{5,6
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Primary end point outcomes^{3
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Clinical cure rates: CANVAS 1 and CANVAS 2

Ceftaroline fosamil ( ZINFORO^® ) 600 mg q12h demonstrated comparable efficacy versus vancomycin plus aztreonam 1 g q12h in terms of clinical cure rates.

Non-inferiority was defined as a lower limit of the 95% CI ≥−10% for the between-group difference. If this was achieved, the protocol stated that superiority would be concluded if the lower limit of the 95% CI ≥0.5%. The safety profile of ZINFORO^® (ceftaroline fosamil) 600 mg q8h was similar to those in the previous trials of 600 mg q12h, with no new safety signals identified.⁴​​​ ​​​​​​​

CAP, community-acquired pneumonia; CANVAS, CeftAroliNe fosamil vs Vancomycin in Skin and skin structure infection; CE, clinically evaluable; cSSTI; cSSTI, complicated skin and soft tissue infection; EOT, end of treatment; IV, intravenous; LFU, late follow-up; MITT, modified intent-to-treat; q8h, every 8 hours; q12h, every 12 hours; TOC, test-of-cure.
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