cSSTI pivotal clinical studies
Pivotal phase III ceftaroline fosamil (Zinforo™) cSSTI studies
The efficacy and tolerability of ceftaroline fosamil (Zinforo® ) monotherapy has been consistently demonstrated in six large, double-blind, phase III, randomised, controlled clinical trials – three involving adult patients with cSSTI and three in patients with CAP.2-5
Ceftaroline fosamil (Zinforo® ) safety and efficacy has also been examined in two clinical studies involving paediatric patients with cSSTI and CAP.6,7
Primary endpoint outcomes4
Clinical cure rates: CANVAS 1 and 2
Ceftaroline fosamil (Zinforo™) 600 mg every 12 hours demonstrated comparable efficacy vs vancomycin plus aztreonam 1 g every 12 hours 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 ceftaroline fosamil (Zinforo™) 600 mg every 8 hours was similar to those in the previous trials of 600 mg every 12 hours, with no new safety signals identified.5
CAP: community-acquired pneumonia; CANVAS: CeftAroliNe fosamil vs Vancomycin in Skin and skin structure infection; CE: clinically evaluable; CI: confidence interval; COVERS: CeftarOline versus Vancomycin and aztrEonam tReating cSSTI; cSSTI: complicated skin and soft tissue infections; IV: intravenous; LFU: late follow-up; ME: microbiologically evaluable; MITT: modified intent-to-treat; mMITT: microbiological modified intent-to-treat; PK: pharmacokinetic; TOC: test of cure.
1. ZINFORO® (ceftaroline fosamil). Local Product Document of Ceftaroline; LPDZIN072021.
2. File TM, Low DE, Eckburg PB, et al. Clin Infect Dis 2010;51:1395–405;
3. Zhong N, et al. Lancet Infect Dis 2015;15:161–71;
4. Corey G, et al. Clin Infect Dis 2010;51:641–50;
5. Dryden M, et al. J Antimicrob Chemother 2016;71:3575–84;
6. Korczowski B, et al. Pediatr Infect Dis J 2016;35:e239–47;
7. Cannavino CR, et al. Pediatr Infect Dis J 2016;35:752–9.
PP-ZFO-IND-0279. 09 December 2021
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