| 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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MedLine Citation:
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PMID: 20695801 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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G Ralph Corey; Mark Wilcox; George H Talbot; H David Friedland; Tanya Baculik; Gary W Witherell; Ian Critchley; Anita F Das; Dirk Thye |
Publication Detail:
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Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America Volume: 51 ISSN: 1537-6591 ISO Abbreviation: Clin. Infect. Dis. Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-08-24 Completed Date: 2010-12-06 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9203213 Medline TA: Clin Infect Dis Country: United States |
Other Details:
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Languages: eng Pagination: 641-50 Citation Subset: IM |
Affiliation:
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Duke Clinical Research Institute, Durham, North Carolina 27715, USA. corey001@mc.duke.edu |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00423657; NCT00424190 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Aged, 80 and over Anti-Bacterial Agents / administration & dosage, adverse effects, pharmacology Aztreonam / administration & dosage, adverse effects*, pharmacology* Cephalosporins / administration & dosage, adverse effects*, pharmacology* Double-Blind Method Drug Therapy, Combination / methods Female Humans Male Middle Aged Skin Diseases, Bacterial / drug therapy* Treatment Outcome Vancomycin / administration & dosage, adverse effects*, pharmacology* Young Adult |
| Chemical | |
Reg. No./Substance:
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0/Anti-Bacterial Agents; 0/Cephalosporins; 0/T 91825; 1404-90-6/Vancomycin; 78110-38-0/Aztreonam |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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