Show simple item record Corey, GR Wilcox, M Talbot, GH Friedland, HD Baculik, T Witherell, GW Critchley, I Das, AF Thye, D
dc.coverage.spatial United States 2012-11-01T20:21:11Z 2010-09-15
dc.identifier.citation Clin Infect Dis, 2010, 51 (6), pp. 641 - 650
dc.description.abstract 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: identifiers: NCT00424190 for CANVAS 1 and NCT00423657 for CANVAS 2.
dc.format.extent 641 - 650
dc.language ENG
dc.relation.ispartof Clin Infect Dis
dc.relation.isversionof 10.1086/655827
dc.subject Adolescent
dc.subject Adult
dc.subject Aged
dc.subject Aged, 80 and over
dc.subject Anti-Bacterial Agents
dc.subject Aztreonam
dc.subject Cephalosporins
dc.subject Double-Blind Method
dc.subject Drug Therapy, Combination
dc.subject Female
dc.subject Humans
dc.subject Male
dc.subject Middle Aged
dc.subject Skin Diseases, Bacterial
dc.subject Treatment Outcome
dc.subject Vancomycin
dc.subject Young Adult
dc.title 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.
dc.type Journal Article
duke.description.endpage 650 en_US
duke.description.issue 6 en_US
duke.description.startpage 641 en_US
duke.description.volume 51 en_US
dc.relation.journal Clinical Infectious Diseases en_US
pubs.issue 6
pubs.organisational-group /Duke
pubs.organisational-group /Duke/Institutes and Provost's Academic Units
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/University Institutes and Centers
pubs.organisational-group /Duke/Institutes and Provost's Academic Units/University Institutes and Centers/Global Health Institute
pubs.organisational-group /Duke/School of Medicine
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Medicine
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Medicine/Medicine, Infectious Diseases
pubs.organisational-group /Duke/School of Medicine/Clinical Science Departments/Pathology
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers
pubs.organisational-group /Duke/School of Medicine/Institutes and Centers/Duke Clinical Research Institute
pubs.publication-status Published
pubs.volume 51
dc.identifier.eissn 1537-6591

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