{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T08:57:52Z","timestamp":1762505872152},"reference-count":19,"publisher":"American Society for Microbiology","issue":"5","license":[{"start":{"date-parts":[[2012,5,1]],"date-time":"2012-05-01T00:00:00Z","timestamp":1335830400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2012,5]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            Scientific and regulatory interest in assessing clinical endpoints after 48 to 72 h of treatment for acute bacterial skin and skin structure infections (ABSSSI) has increased. Historical, pre-antibiotic-era data suggest that a treatment effect relative to untreated controls can be discerned in this time interval. Ceftaroline fosamil, a broad-spectrum bactericidal cephalosporin with activity against Gram-positive organisms, including methicillin-resistant\n            <jats:named-content xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" content-type=\"genus-species\" xlink:type=\"simple\">Staphylococcus aureus<\/jats:named-content>\n            (MRSA), and Gram-negative organisms was efficacious in two phase 3 trials of complicated skin infections (CANVAS 1 and 2) using clinical cure rates at the test-of-cure visit. To assess an early clinical response in the CANVAS trials, a retrospective analysis using a day 3 clinical endpoint was conducted. Adults with ABSSSI received intravenous ceftaroline fosamil at 600 mg every 12 h (q12h) or vancomycin at 1 g plus aztreonam at 1 g (V\/A) q12h for 5 to 14 days. Clinical response at day 3, defined as cessation of infection spread and absence of fever, was analyzed in patients with a lesion size of \u226575 cm\n            <jats:sup>2<\/jats:sup>\n            and either deep and\/or extensive cellulitis, major abscess, or an infected wound. Day 3 integrated CANVAS clinical response rates were 74.0% (296\/400) for ceftaroline and 66.2% (263\/397) for V\/A (difference, 7.8%; 95% confidence interval [CI], 1.3% to 14.0%). In the individual studies, absolute treatment differences of 9.4% (CANVAS 1) and 5.9% (CANVAS 2) favoring ceftaroline were observed. For ABSSSI due to MRSA, response rates were 81.7% and 77.4% in the ceftaroline and V\/A groups, respectively. In this retrospective analysis, ceftaroline fosamil monotherapy had a numerically higher clinical response than V\/A at day 3 in the treatment of ABSSSI.\n          <\/jats:p>","DOI":"10.1128\/aac.05738-11","type":"journal-article","created":{"date-parts":[[2012,2,7]],"date-time":"2012-02-07T05:51:54Z","timestamp":1328593914000},"page":"2231-2236","update-policy":"http:\/\/dx.doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":60,"title":["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"],"prefix":"10.1128","volume":"56","author":[{"given":"H. David","family":"Friedland","sequence":"first","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tanya","family":"O'Neal","sequence":"additional","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Donald","family":"Biek","sequence":"additional","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul B.","family":"Eckburg","sequence":"additional","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas R.","family":"Rank","sequence":"additional","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lily","family":"Llorens","sequence":"additional","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alex","family":"Smith","sequence":"additional","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary W.","family":"Witherell","sequence":"additional","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph B.","family":"Laudano","sequence":"additional","affiliation":[{"name":"Forest Research Institute, Inc., Jersey City, New Jersey, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dirk","family":"Thye","sequence":"additional","affiliation":[{"name":"Cerexa, Inc., Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1086\/655827"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkq254"},{"key":"e_1_3_2_4_2","doi-asserted-by":"crossref","first-page":"ii37","DOI":"10.1093\/jac\/dkh202","article-title":"Complicated infections of skin and skin structures: when the infection is more than skin deep","volume":"53","author":"DiNubile MJ","year":"2004","unstructured":"DiNubileMJ LipskyBA. 2004. Complicated infections of skin and skin structures: when the infection is more than skin deep. J. Antimicrob. Chemother. 53(Suppl.):ii37\u2013ii50.","journal-title":"J. Antimicrob. Chemother."},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1086\/526444"},{"key":"e_1_3_2_6_2","first-page":"s15","article-title":"Optimal antibacterial treatment of uncomplicated skin and skin structure infections: applying a novel treatment algorithm","volume":"4","author":"Elston DM","year":"2005","unstructured":"ElstonDM. 2005. Optimal antibacterial treatment of uncomplicated skin and skin structure infections: applying a novel treatment algorithm. J. Drugs Dermatol. 4(Suppl.):s15\u2013s19.","journal-title":"J. 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Early switch from intravenous to oral antibiotics: guidelines and implementation in a large teaching hospital. J. Antimicrob. Chemother. 43:601\u2013606.","journal-title":"J. Antimicrob. Chemother."},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.2.3993.101"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.2.4014.1156"},{"key":"e_1_3_2_16_2","doi-asserted-by":"crossref","first-page":"383","DOI":"10.1086\/600296","article-title":"Antimicrobial agents for complicated skin and skin structure infections: justification of noninferiority margins in the absence of placebo-controlled trials","volume":"49","author":"Spellberg B","year":"2009","unstructured":"SpellbergB. 2009. Antimicrobial agents for complicated skin and skin structure infections: justification of noninferiority margins in the absence of placebo-controlled trials. Clin. Infect. Dis. 49:383\u2013391.","journal-title":"Clin. Infect. 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Uncomplicated and complicated skin and skin structure infections\u2014developing antimicrobial drugs for treatment. 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