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Abstract
Evaluation of: Friedland DH, O’Neal T, Biek D et al. CANVAS 1 and 2: analysis of clinical response at day 3 in two Phase 3 trials of ceftaroline fosamil versus vancomycin plus aztreonam in treatment of acute bacterial skin and skin structure infections. Antimicrob. Agents Chemother. 56, 2231–2236 (2012).
The US FDA recently approved ceftaroline fosamil (ceftaroline) for the treatment of acute bacterial skin and soft structure infections (ABSSSIs) and community-acquired pneumonia. In 2010, the FDA specified a new primary end point for ABSSSI of 3 days instead of the traditional test of cure. Friedland et al. used the new FDA end point in evaluating the CANVAS 1 and 2 trials. In the exploratory modified, intention-to-treat analysis, ceftaroline showed a superior clinical response at day 3 (74 vs 66.2%; difference 7.7%; 95% CI: 1.3–14%). The superior response of ceftaroline has biologic plausibility based on the in vitro activity of the antibiotic, suggesting that a true early clinical benefit may exist. However, owing to the potential for selection bias and lack of logistic regression analysis, caution should be used when extrapolating these results to clinical practice. Future trials utilizing this new end point in prospective ABSSSI trials will show over time the true value of such an end point.
Financial & competing interests disclosure
LB Johnson received a consulting fee from Forest Laboratories in 2010. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.