| Title: |
FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia |
| Authors: |
File, Thomas M.; Low, Donald E.; Eckburg, Paul B.; Talbot, George H.; Friedland, H. David; Lee, Jon; Llorens, Lily; Critchley, Ian A.; Thye, Dirk A.; on behalf of the FOCUS 1 investigators; Pullman, John; Giordano, Philip; Welker, James; Manos, Paul; Mehra, Purvi; File, Thomas; De Santo, Joseph; Venkateswaralu, Bhaskar; Gerald Schrock, Christian; Tillis, William; Winetz, Jan Alan; Gonzalez, J. Mario; Ramage, Anthony; Eisenhower, Dwight D.; Koegelenberg, Coenie; Engelbrecht, Ingrid; Jurgens, Jaco; Mitha, Ishmail; Breedt, Johannes; Gani, Mashra; Roos, Johannes; Basson, Matthys; Van Zyl, Louis; Meeding, Ronel; Fulat, Muhammed; Le Roux, Marius; Bonvehi, Pablo Eduardo; Ganaha, Maria Cristina; Gurini, Ana Leticia; Daniel Lopardo, Gustavo; Cristina, Lucia; Edwardo Prieto, Sergio; Rodiguez, Claudia Gabriela; Augusto Teijeiro, Ricardo; Carmen Pallone, Elida; Pryluka, Daniel Horacio; da Cunha, Clovis Arns; da Silva, Nilton Brandao; de Faria Freire, Antonio Tarcisio; Ferreira Starling, Carlos Ernesto; Costa Fiterman, Jussara; Góngora Rubio, Fernando; Carlos Losso, Luis; Patelli, Maria; Souza Lima, Juliani; Zimermann Teixeira, Paulo José; Carmo Moreira, Maria Auxiliadora; Abreu de Oliveira, Julio César; Roudas, Vsevolod; Gamal, Evgeny A.; Leschenko, Igor; Rudnov, Vladimir A.; Yevdokimova, Anna G.; Vertkin, Arkadiy L.; Ambalov, Yuriy M.; Dvoryashina, Irina V.; Zilber, Elmira; Khamitov, Rustem F.; Galustyan, Anna N.; Reshetko, Olga V.; Senior, Victoria Arama; Grosan, Mihaela Flavia; Jimborean, Gabriela; Lupse, Mihaela; Aron, Gheorgita; Olteanu, Dan; Puschita, Maria; Gavris, Claudia; Tudorache, Voicu Mircea; Youroukova, Vania; Petkova, Mila; Troshanova, Evelina; Dzhabalyan, Mari; Kavtaradze, George; Makhviladze, Manana; Tabukashvili, Revaz; Pons, Marco; Garbino, Jorge; Genne, Daniel; Rothen, Madeleine; de Saracho, Juan Oriz; Capelastegui, Alberto; Menendez, Rosario; Torres, Antoni; Shum, Conrado; Falco, Vincenç; Bouza, Emilio; Bru, Jean-Pierre; Misset, Benoit; Megarbane, Bruno; Sollet, Jean Pierre; Molina, Jean-Michel; Dalhoff, Klaus; Lorenz, Joachim; Petermann, Wolfgang; Rohde, Gernot; Schumann, Christian; Tasci, Selcuk; Zerbst, Joachim; Auch-Schwelk, Wolfgang; Suttorp, Norbert; Henrich, Rolf; Fertl, Andreas; Grohe, Christian; Jakobeit, Christian; Deppermann, Karl-Matthius; Batura-Gabryel, Halina; Pupek-Musialik, Danuta; Piotrowicz, Pawe; Marcisz, Czeslaw; Czarnobilski, Krzysztof; Jankowska, Renata; Janik, Krzysztof; Gutowska-Jablonska, Malgorzata; Hamankiewicz, Maciej; Kus, Jan; Rydzewski, Andrzej; Dulawa, Jan; Ziolko, Ewa; Baranska, Eliza; Wendland, Marian; Trebas-Pietras, Ewa; Tyszkiewic, Ireneusz; Bonelli, Johannes; Balikó, Zoltán; Bisits, Márta; Losonczy, Gyorgy; Mark, Zsuzsa; Albert, Istvan; Francovszky, Eva; Fonay, Karoly; Tetiana Pertseva, Tetiana; Yefimov, Volodymyr; Havrysyuk, Volodymyr; Melnyk, Vasyl; Yashyna, Lyudmyla; Monogarova, Nadiya; Kolchyn, Yuriy; Dutka, Roman; Smolyanyi, Oleksandr; Tryshchuk, Nadiya; Kaydashev, Igor; Rodionova, Victoria; Neyko, Vasyl; Chopey, Ivan; Alekniene, Birute; Kramilius, Ginataras; Naudziunas, Stanislovas; Miliauskas, Skaidrius; Nausediene, Vitalija; Valavicius, Arvydas; Mitic-Milikic, Marija; Celeketic, Dusica; Lazic, Zorica; Milinic, Nikola; Pejcic, Tatjana; Sukles, Kai; Jaanus, Martti; Meriste, Sulev; Ahmad Mahayiddin, Datin Hjh Aziah; Bin Abdul Muttalif, Abdul Pazak; Kuang Kiat, Kiew; Binte, Roslina; Manap, Abdul; bt Md Tarekh, Noor Aliza; Anekthananon, Thanomsak; Mootsikapun, Piroon; Intalapaporn, Poj; Pothirat, Chaicharn; Horsin, Pinyo; Churchottaworn, Charoen; Wattanathum, Anan; Dukat, Andrej; Plutinsky, Jan |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2011 |
| Collection: |
HighWire Press (Stanford University) |
| Subject Terms: |
Articles |
| Description: |
Objectives 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. Methods 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. Patients also received two 500 mg doses of oral clarithromycin every 12 h administered on day 1. Clinical cure, microbiological response, adverse events (AEs) and laboratory tests were assessed. FOCUS 1 registration number NCT00621504 ( http://clinicaltrials.gov/ct2/show/NCT00621504 ). Results Of 613 enrolled patients, 298 received ceftaroline fosamil and 308 received ceftriaxone. Baseline characteristics between treatment groups were comparable. Clinical cure rates were as follows: CE population, 86.6% (194/224) for ceftaroline fosamil and 78.2% (183/234) for ceftriaxone [difference (95% CI), 8.4% (1.4, 15.4)]; and MITTE population, 83.8% (244/291) for ceftaroline fosamil and 77.7% (233/300) for ceftriaxone [difference (95% CI), 6.2% (−0.2, 12.6)]. Clinical cure rates for CAP caused by S. pneumoniae in the microbiological MITTE population were 88.9% (24/27) and 66.7% (20/30) for ceftaroline fosamil and ceftriaxone, respectively. Both agents were well tolerated, with similar rates of AEs, ... |
| Document Type: |
text |
| File Description: |
text/html |
| Language: |
English |
| Relation: |
http://jac.oxfordjournals.org/cgi/content/short/66/suppl_3/iii19; http://dx.doi.org/10.1093/jac/dkr096 |
| DOI: |
10.1093/jac/dkr096 |
| Availability: |
http://jac.oxfordjournals.org/cgi/content/short/66/suppl_3/iii19; https://doi.org/10.1093/jac/dkr096 |
| Rights: |
Copyright (C) 2011, The British Society for Antimicrobial Chemotherapy |
| Accession Number: |
edsbas.1F3F0AC |
| Database: |
BASE |