Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection.
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2010-09-15
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BACKGROUND: Methicillin-resistant Staphylococcus aureus (MRSA) is a common cause of complicated skin and skin-structure infection (cSSSI). Increasing antimicrobial resistance in cSSSI has led to a need for new safe and effective therapies. Ceftaroline was evaluated as treatment for cSSSI in 2 identical phase 3 clinical trials, the pooled analysis of which is presented here. The primary objective of each trial was to determine the noninferiority of the clinical cure rate achieved with ceftaroline monotherapy, compared with that achieved with vancomycin plus aztreonam combination therapy, in the clinically evaluable (CE) and modified intent-to-treat (MITT) patient populations. METHODS: Adult patients with cSSSI requiring intravenous therapy received ceftaroline (600 mg every 12 h) or vancomycin plus aztreonam (1 g each every 12 h) for 5-14 days. RESULTS: Of 1378 patients enrolled in both trials, 693 received ceftaroline and 685 received vancomycin plus aztreonam. Baseline characteristics of the treatment groups were comparable. Clinical cure rates were similar for ceftaroline and vancomycin plus aztreonam in the CE (91.6% vs 92.7%) and MITT (85.9% vs 85.5%) populations, respectively, as well as in patients infected with MRSA (93.4% vs 94.3%). The rates of adverse events, discontinuations because of an adverse event, serious adverse events, and death also were similar between treatment groups. CONCLUSIONS: Ceftaroline achieved high clinical cure rates, was efficacious against cSSSI caused by MRSA and other common cSSSI pathogens, and was well tolerated, with a safety profile consistent with the cephalosporin class. Ceftaroline has the potential to provide a monotherapy alternative for the treatment of cSSSI. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT00424190 for CANVAS 1 and NCT00423657 for CANVAS 2.
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Corey, G Ralph, Mark Wilcox, George H Talbot, H David Friedland, Tanya Baculik, Gary W Witherell, Ian Critchley, Anita F Das, et al. (2010). Integrated analysis of CANVAS 1 and 2: phase 3, multicenter, randomized, double-blind studies to evaluate the safety and efficacy of ceftaroline versus vancomycin plus aztreonam in complicated skin and skin-structure infection. Clin Infect Dis, 51(6). pp. 641–650. 10.1086/655827 Retrieved from https://hdl.handle.net/10161/5978.
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Gordon Ralph Corey
My research is based at the Duke Clinical Research Institute, a large academic clinical research organization designed to conduct clinical trials from small local studies to worldwide trials. The focus of my research is bacterial infections: complicated skin and skin structure infections; postoperative wound infections; hospital-acquired and ventilator-associated pneumonia; bacteremia; and endocarditis. Many of these trials are conducted in concert with the pharmaceutical industry in order to register new antibiotics. In addition, as director of infectious diseases at the DCRI I oversee the work of the mycology group, and tuberculosis trials. This work also includes work supported by NIH grants including sepsis trials, the Staph Aureus and Staph Epi Bacteremia Groups, and the International Collaboration of Endocarditis. The team of investigators with whom I work is highly experienced, amazingly productive and wonderfully collegial.
As a result of my longstanding interest in tropical medicine and the generosity of my patients as well as the Hubert Family we have been able to establish the Hubert-Yeargan Center for Global Health. As a result we have developed a medical center-wide fellowship in Global Health. I am presently the Director of the Center and the Gary Hock Distinguished Professor of Global Health.
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