Consistent efficacy was demonstrated in patients with CAP across 2 Phase III trials1
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The lower limit of the 95% CI was ≥–10%, which met the predefined criteria for non-inferiority.1
ZINFORO® demonstrated superiority to ceftriaxone 2 g in the follow-up Phase III Asia CAP study2,*
ZINFORO® Phase III Asia CAP study design2:
*The primary objective was to assess the clinical cure rates at the TOC visit (8-15 days after the last dose) in the CE population; 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%.2
The between-group difference (95% CI) was 9.9% (2.8-17.1), demonstrating the superiority of ZINFORO® to ceftriaxone 2 g in adult patients with PORT risk Class III/IV CAP in Asia.2
CAP, community-acquired pneumonia; CE, clinically evaluable; CI, confidence interval; FOCUS, ceftaroline community-acquired pneumonia trial versus ceftriaxone in hospitalised patients; MITTE, modified intent-to-treat efficacy; PORT, Pneumonia Patient Outcomes Research Team; q12h, every 12 hours; q24h, every 24 hours; TOC, test of cure.
References:
Safety profile consistent with other cephalosporins
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