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Text
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URL Address
<a href="http://doi.org/10.1086/657313" target="_blank" rel="noreferrer noopener">http://doi.org/10.1086/657313</a>
Pages
1395–1405
Issue
12
Volume
51
Dublin Core
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Title
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Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia.
Publisher
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Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Date
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2010
2010-12
Subject
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80 and over; Administration; Adult; Aged; Anti-Bacterial Agents/*administration & dosage/*adverse effects; Bacterial/*drug therapy; Ceftriaxone/*administration & dosage/*adverse effects; Cephalosporins/*administration & dosage/*adverse effects; Community-Acquired Infections/drug therapy; Double-Blind Method; Female; Humans; Infusions; Intravenous; Male; Middle Aged; Oral; Pneumonia; Treatment Outcome
Creator
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File Thomas M Jr; Low Donald E; Eckburg Paul B; Talbot George H; Friedland H David; Lee Jon; Llorens Lily; Critchley Ian; Thye Dirk
Description
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BACKGROUND: Ceftaroline, the active form of ceftaroline fosamil, is a broad-spectrum cephalosporin with bactericidal activity against pathogens causing community-acquired pneumonia (CAP), including Streptococcus pneumoniae. Ceftaroline was evaluated for the treatment of CAP in 2 randomized, double-blind, multicenter trials: Ceftaroline Community Acquired Pneumonia Trial versus Ceftriaxone in Hospitalized Patients (FOCUS) 1 and FOCUS 2. METHODS: Patients hospitalized (but not admitted to an intensive care unit) with Pneumonia Outcomes Research Team risk class III or IV CAP requiring intravenous therapy were randomized to ceftaroline 600 mg every 12 h or ceftriaxone 1 g every 24 h for 5-7 days. Patients in FOCUS 1 received 2 doses of oral clarithromycin 500 mg every 12 h on day 1. RESULTS: In the individual trials, clinical cure rates in the clinically evaluable (CE) population for ceftaroline versus ceftriaxone were as follows: FOCUS 1, 86.6% vs 78.2% (difference, 8.4%; 95% confidence interval [CI], 1.4%-15.4%); FOCUS 2, 82.1% vs 77.2% (difference, 4.9%; 95% CI, -2.5% to 12.5%). In the integrated analysis, 614 patients received ceftaroline and 614 received ceftriaxone. Of the CE patients treated with ceftaroline, 84.3% achieved clinical cure, compared with 77.7% of ceftriaxone-treated patients (difference, 6.7%; 95% CI, 1.6%-11.8%). Clinical cure rates in the modified intent-to-treat efficacy population were 82.6% versus 76.6% for ceftaroline and ceftriaxone (difference, 6.0%; 95% CI, 1.4%-10.7%). Ceftaroline and ceftriaxone were well tolerated; rates of adverse events, serious adverse events, deaths, and premature discontinuations caused by an adverse event were similar in both treatment arms. CONCLUSIONS: Ceftaroline was noninferior to ceftriaxone in the individual trials. In this integrated analysis, clinical cure rates for the ceftaroline group were numerically higher than those for the ceftriaxone group. Ceftaroline was well tolerated, with a safety profile similar to that of ceftriaxone.
Identifier
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<a href="http://doi.org/10.1086/657313" target="_blank" rel="noreferrer noopener">10.1086/657313</a>
Rights
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Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2010
80 and over
Administration
Adult
Aged
Anti-Bacterial Agents/*administration & dosage/*adverse effects
Bacterial/*drug therapy
Ceftriaxone/*administration & dosage/*adverse effects
Cephalosporins/*administration & dosage/*adverse effects
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Community-Acquired Infections/drug therapy
Critchley Ian
Department of Internal Medicine
Double-Blind Method
Eckburg Paul B
Female
File Thomas M Jr
Friedland H David
Humans
Infusions
Intravenous
Lee Jon
Llorens Lily
Low Donald E
Male
Middle Aged
NEOMED College of Medicine
Oral
Pneumonia
Talbot George H
Thye Dirk
Treatment Outcome