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FOCUS 2: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia

2011; Oxford University Press; Volume: 66; Issue: suppl_3 Linguagem: Inglês

10.1093/jac/dkr097

1460-2091

Donald E. Low, Thomas M. File, Paul B. Eckburg, George H. Talbot, H. David Friedland, Jon Lee, Lily Llorens, Ian A. Critchley, Dirk Thye, Jorge Corral, Eduardo Giugno, Maria del Rosario Gonzalez Arzac, Diego Maurizi, Javier Altclas, Germán Ambasch, Abel Jasovich, Angel Ramon Minguez, María Eugenia Oliva, Osvaldo Teglia, Carlos Bergallo, María Mastruzzo, Graciana Morera, Pabio Gustavo Scapellato, Ricardo Lamberghini, Analía Mykietiuk, Christian Remolif, Manuel Jose Barros Monge, Maria Isabel Enriqueta Campos Barker, Sara Mireya Chernilo Steinmann, Pablo Antonio Gaete Gutierrez, Sylvia Susana Muñoz Vejar, Mario Andres Calvo Arellano, Carolina Eugenia Chahin Anania, Arturo Jáuregui Cruz, Gerardo Amaya Tapia, Moises Acuna Kaldman, Eduardo Rodríguez-Noriega, E Prado, Carlos A. Ramos, Irina V. Andreeva, Р. А. Абышев, Yuri Antonovsky, Marina Balyuzek, Alla L. Esina, Alexander Gorelov, О.А. Хрусталев, Roman S. Kozlov, Vladislav Novozhenok, Veronika B. Popova, Svetlana Sobchenko, В. И. Трофимов, S B Yakovlev, К. П. Жидков, Luminta Gabriela Ambert, Carmen Georgeta Fierbinteau, Valentina Ionescu, Mihai Marius Muresan, Cristina Tănăseanu, Ognian Georgiev, Valdimir Hodzhev, Rosen Marinov, Hristo Metev, M Peneva, Dimitar Popov, Milkana Simeonova, Ivars Krastiņš, Viktors Lovcinovsk, Viesturs Šiliņš, Vita Svarcberga, Joachim Bargon, T. Bauer, Rolf Bergmann, F. Meyer, Thomas Mueller, Tobias Welte, Sven Glaeser, Peter Hammerl, Hartmut Kern, Stefan Krueger, P. Kujath, Achim Lies, Tom Schaberg, Oliver Schmalz, Wolfgang Schütte, Ryszarda Chazan, Dorota Górecka, Barbara Rogala, Adam Antczak, Tomasz Grodzicki, Karina Jahnz—Rö, Janusz Milanowski, P Nalepa, Malgorzata Wróbel-Rajzer, Hanna Szelerska-Twardosz, I Grzelewska-Rzymowska, Tomasz Kachel, Andrzej Marciniak, Bernard Panaszek, Andrzej Szczeklik, Jerzy Kozielski, Rafał Harat, Dariusz Jastrzebsk, Jacek Juszczak, Violetta Labij, N. Vetter, J Bolitschek, Josef Eckmayr, Sándor Molnár, Zsolt Pápai-Székely, János Szegedi, Ilona Vinkler, Mykhaylo Borscchivskyy, Oleksandr Dziublyk, G. V. Dzyak, Oleg Kraydaschenko, Yuriy Mostovoy, Iurii Rudyk, V. Sushko, Вадим Анатолійович Візір, Amal Bhattacharya, Mahabala Chakrapan, George D’Souza, G.S. Malpani, Parthiv Mehta, KL Narasimha Rao, Deepak Talwar,

Nosocomial Infections in ICU

Ceftaroline (active form of the prodrug ceftaroline fosamil) is a novel cephalosporin with activity against pathogens commonly associated with community-acquired pneumonia (CAP), including Streptococcus pneumoniae and Gram-negative pathogens. This randomized, double-blind, Phase III study evaluated the efficacy and safety of ceftaroline fosamil in treating patients with CAP. The primary objective was to determine non-inferiority [lower limit of 95% confidence interval (CI) ≥ -10%] of clinical cure rates achieved with ceftaroline fosamil compared with those achieved with ceftriaxone in the clinically evaluable (CE) and modified intent-to-treat efficacy (MITTE) populations.Patients hospitalized in a non-intensive care unit setting with CAP of Pneumonia Outcomes Research Team (PORT) risk class III or IV requiring intravenous (iv) therapy were randomized (1:1) to receive 600 mg of ceftaroline fosamil iv every 12 h or 1 g of ceftriaxone iv every 24 h. Clinical cure, microbiological response, adverse events (AEs) and laboratory tests were assessed. FOCUS 2 registration number NCT00509106 (http://clinicaltrials.gov/ct2/show/NCT00509106).The study enrolled 627 patients, 315 of whom received ceftaroline fosamil and 307 of whom received ceftriaxone. Patients in both treatment groups had comparable baseline characteristics. Clinical cure rates were as follows: CE population, 82.1% (193/235) for ceftaroline fosamil and 77.2% (166/215) for ceftriaxone [difference (95% CI), 4.9% (-2.5, 12.5)]; and MITTE population, 81.3% (235/289) for ceftaroline fosamil and 75.5% (206/273) for ceftriaxone [difference (95% CI), 5.9% (-1.0, 12.7)]. Clinical cure rates for CAP caused by S. pneumoniae in the microbiological MITTE (mMITTE) population were 83.3% (35/42) and 70.0% (28/40) for ceftaroline fosamil and ceftriaxone, respectively. Ceftaroline fosamil and ceftriaxone were well tolerated, with similar rates of AEs, serious AEs, deaths and discontinuations due to an AE. The most common AEs for ceftaroline fosamil-treated patients were diarrhoea, headache, hypokalaemia, insomnia and phlebitis, and the most common AEs for ceftriaxone-treated patients were diarrhoea, insomnia, phlebitis and hypertension.Ceftaroline fosamil achieved high clinical cure and microbiological response rates in patients hospitalized with CAP of PORT risk class III or IV. Ceftaroline fosamil was well tolerated, with a safety profile that is similar to that of ceftriaxone and other cephalosporins. Ceftaroline fosamil is a promising agent for the treatment of CAP.