TY - JOUR T1 - 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. AU - Friedland,H David, AU - O'Neal,Tanya, AU - Biek,Donald, AU - Eckburg,Paul B, AU - Rank,Douglas R, AU - Llorens,Lily, AU - Smith,Alex, AU - Witherell,Gary W, AU - Laudano,Joseph B, AU - Thye,Dirk, Y1 - 2012/02/06/ PY - 2012/2/9/entrez PY - 2012/2/9/pubmed PY - 2012/8/18/medline SP - 2231 EP - 6 JF - Antimicrobial agents and chemotherapy JO - Antimicrob Agents Chemother VL - 56 IS - 5 N2 - 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 Staphylococcus aureus (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 ≥ 75 cm(2) 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. SN - 1098-6596 UR - https://www.unboundmedicine.com/medline/citation/22314524/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_ L2 - https://journals.asm.org/doi/10.1128/AAC.05738-11?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -