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FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia
Author(s) -
Thomas M. File,
Donald E. Low,
Paul B. Eckburg,
George H. Talbot,
H. David Friedland,
Jon Lee,
Lily Llorens,
Ian A. Critchley,
Dirk Thye,
John Pullman,
Philip Giordano,
James Welker,
Paul Manos,
P. Mehra,
Joana Espírito Santo,
B. Venkateswaralu,
C. G. Schrock,
William Tillis,
Jan A. Winetz,
Javier González,
Andrew G. Ramage,
Dwight D. Eisenhower,
Coenraad F.N. Koegelenberg,
Ingrid Engelbrecht,
Julie A. Jurgens,
Ismail Mitha,
J. Breedt,
Mashra Gani,
Jack Roos,
Marc D. Basson,
Louis van Zyl,
Ronel Meeding,
Muhammed Ameen Fulat,
M. Le Roux,
Pablo Bonvehí,
María Cristina Ganaha,
A. L. Gurini,
Gustavo Lopardo,
Laura Cristina,
Sergio Prieto,
Celestino Rodíguez,
Ricardo Teijeiro,
E Pallone,
Daniel Pryluka,
Clóvis Arns da Cunha,
N. B. da Silva,
António Freire,
Cláudia Starling,
J. Costa Fiterman,
Fernando Gôngora Rubio,
L. Carlos Losso,
Marco Patelli,
J. Souza Lima,
Paulo José Zimermann Teixeira,
Marta Moreira,
J. C. Abreu de Oliveira,
V. Roudas,
E. A. Gamal,
I. V. Leschenko,
В. А. Руднов,
A. G. Yevdokimova,
A. L. Vertkin,
Y. M. Ambalov,
I. V. Dvoryashina,
E. Zilber,
R. F. Khamitov,
A. N. Galustyan,
O. V. Reshetko,
Victoria Senior,
M. F. Grosan,
Gabriela Jimborean,
M. Lupse,
G. Aron,
Dan Olteanu,
Maria Puşchiţă,
Claudia Gavriș,
V. M. Tudorache,
Vania Youroukova,
M Petkova,
E. Troshanova,
M. Dzhabalyan,
G Kavtaradze,
M. Makhviladze,
R. Tabukashvili,
Marco Pons,
Jorge Garbino,
Daniel Genné,
Madeleine Rothen,
J. O. de Saracho,
A. Capelastegui,
Rosario Menéndez,
Antoní Torres,
C. Shum,
Vicenç Falcó,
Emilio Bouza,
J.P. Bru,
Benoît Misset,
Bruno Mégarbane,
J.-P. Sollet,
J.-M. Molina,
K. Dalhoff,
J. Lorenz,
W Petermann,
Gernot Rohde,
C. Schumann,
Sultan Taşçı,
J. Zerbst,
Wolfgang Auch–Schwelk,
Norbert Suttorp,
Rolf Henrich,
Andreas Fertl,
C. Grohe,
C. Jakobeit,
K.-M. Deppermann,
Halina BaturaGabryel,
Danuta PupekMusialik,
Pawel Piotrowicz,
Czesław Marcisz,
K Czarnobilski,
Renata Jankowska,
Krzysztof Janik,
M. Gutowska-Jablonska,
Maciej Hamankiewicz,
Jan Kuś,
Andrzej Rydzewski,
Jan Duława,
Ewa Ziółko,
Edyta Barańska,
Michael F. Wendland,
Ewa Trębas-Pietraś,
I. Tyszkiewic,
J Bonelli,
Zoltán Balikó,
M. Bisits,
G. Losonczy,
Z. Mark,
I. Albert,
E. Francovszky,
Károly Fónay,
Tetiana Pertseva,
Valentyn Yefimov,
V. Havrysyuk,
Victor Melnyk,
L. A. Yashyna,
Н. Е. Моногарова,
Y. Kolchyn,
R.Ya. Dutka,
O. Smolyanyi,
Nadiya Tryshchuk,
І. P. Kaydashev,
Valeria Rodionova,
Vasyl Neyko,
Ivan V. Chopey,
B. Alekniene,
G. Kramilius,
S. Naudziunas,
Skaidrius Miliauskas,
V. Nausediene,
Arvydas Valavičius,
Marija Mitić-Milikić,
Dušica Čeleketić,
Zorica Lazić,
Nikola Milinić,
Tatjana Pejčić,
Kai Sukles,
Martin Jaanus,
Sirli Meriste,
D. H. A. Ahmad Mahayiddin,
A. P. Bin Abdul Muttalif,
Kiew Kuang Kiat,
R. Binte,
Abreeza Manap,
N. A. bt Md Tarekh,
T. Anekthana,
Piroon Mootsikapun,
Poj Intalapaporn,
Chaicharn Pothirat,
Pinyo Horsin,
C. Churchottaworn,
Anan Wattanathum,
Andrej Dukát,
Ján Plutinský
Publication year - 2011
Publication title -
journal of antimicrobial chemotherapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.124
H-Index - 194
eISSN - 1460-2091
pISSN - 0305-7453
DOI - 10.1093/jac/dkr096
Subject(s) - ceftriaxone , medicine , randomized controlled trial , pneumonia , double blinded , antibiotics , alternative medicine , pathology , microbiology and biotechnology , biology , placebo
Ceftaroline, the active form of the prodrug ceftaroline fosamil, is a novel cephalosporin with bactericidal activity against important pathogens associated with community-acquired pneumonia (CAP), including Streptococcus pneumoniae and common Gram-negative pathogens. FOCUS 1 is a randomized, double-blinded, Phase III study that was conducted to evaluate 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%] in 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.

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