1
40
4
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1093/jac/dkv415" target="_blank" rel="noreferrer noopener">http://doi.org/10.1093/jac/dkv415</a>
Pages
862–870
Issue
4
Volume
71
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Ceftaroline fosamil versus ceftriaxone for the treatment of community-acquired pneumonia: individual patient data meta-analysis of randomized controlled trials.
Publisher
An entity responsible for making the resource available
The Journal of antimicrobial chemotherapy
Date
A point or period of time associated with an event in the lifecycle of the resource
2016
2016-04
Subject
The topic of the resource
Anti-Bacterial Agents/*therapeutic use; Bacterial/*drug therapy; Ceftriaxone/*therapeutic use; Cephalosporins/*therapeutic use; Community-Acquired Infections/*drug therapy; Humans; Pneumonia; Randomized Controlled Trials as Topic
Creator
An entity primarily responsible for making the resource
Taboada Maria; Melnick David; Iaconis Joseph P; Sun Fang; Zhong Nan Shan; File Thomas M; Llorens Lily; Friedland H David; Wilson David
Description
An account of the resource
BACKGROUND: We conducted a meta-analysis of clinical trials of adults hospitalized with pneumonia outcomes research team (PORT) risk class 3-4 community-acquired pneumonia (CAP) receiving ceftaroline fosamil versus ceftriaxone. METHODS: Three Phase III trials (clinicaltrials.gov registration numbers NCT00621504, NCT00509106 and NCT01371838) including 1916 hospitalized patients with CAP randomized 1:1 to empirical ceftaroline fosamil (600 mg every 12 h) or ceftriaxone (1-2 g every 24 h) for 5-7 days were included in the meta-analysis. Primary outcome was clinical response at the test-of-cure visit (8-15 days after end of treatment) in the PORT risk class 3-4 modified ITT (MITT) and clinically evaluable (CE) populations. Data were tested for heterogeneity (chi(2) test) and, if not significant, results were pooled and OR and 95% CI constructed. A logistic regression analysis assessed factors impacting cure rate and treatment interactions. RESULTS: Clinical cure rates in each trial consistently favoured ceftaroline fosamil versus ceftriaxone, with no evidence of heterogeneity. In the meta-analysis, ceftaroline fosamil was superior to ceftriaxone in the MITT (OR: 1.66; 95% CI 1.34, 2.06; P \textless 0.001) and CE (OR: 1.65; 95% CI 1.26, 2.16; P \textless 0.001) populations. Results were consistent across various patient- and disease-related factors including patients' age and PORT score. Prior antimicrobial use within 96 h of starting study treatment was associated with diminished differences in cure rates between treatments. CONCLUSIONS: Ceftaroline fosamil was superior to ceftriaxone for empirical treatment of adults hospitalized with CAP. Receipt of prior antimicrobial therapy appeared to diminish the observed treatment effect.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1093/jac/dkv415" target="_blank" rel="noreferrer noopener">10.1093/jac/dkv415</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2016
Anti-Bacterial Agents/*therapeutic use
Bacterial/*drug therapy
Ceftriaxone/*therapeutic use
Cephalosporins/*therapeutic use
Community-Acquired Infections/*drug therapy
Department of Internal Medicine
File Thomas M
Friedland H David
Humans
Iaconis Joseph P
Llorens Lily
Melnick David
NEOMED College of Medicine
Pneumonia
Randomized Controlled Trials as Topic
Sun Fang
Taboada Maria
The Journal of antimicrobial chemotherapy
Wilson David
Zhong Nan Shan
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1093/jac/dkr096" target="_blank" rel="noreferrer noopener">http://doi.org/10.1093/jac/dkr096</a>
Pages
iii19–32
Volume
66 Suppl 3
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
FOCUS 1: a randomized, double-blinded, multicentre, Phase III trial of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in community-acquired pneumonia.
Publisher
An entity responsible for making the resource available
The Journal of antimicrobial chemotherapy
Date
A point or period of time associated with an event in the lifecycle of the resource
2011
2011-04
Subject
The topic of the resource
80 and over; 80 and Over; Aged; Bacteria; Bacteria/isolation & purification; Bacterial – Drug Therapy; Bacterial/*drug therapy; Ceftriaxone – Administration and Dosage; Ceftriaxone – Adverse Effects; Ceftriaxone/administration & dosage/adverse effects; Cephalosporins – Administration and Dosage; Cephalosporins – Adverse Effects; Cephalosporins/*administration & dosage/*adverse effects; Community-Acquired Infections – Drug Therapy; Community-Acquired Infections/*drug therapy; Double-Blind Method; Double-Blind Studies; Female; Human; Humans; Infusions; Intravenous; Male; Middle Age; Middle Aged; Pneumonia; Randomized Controlled Trials; Treatment Outcome; Treatment Outcomes
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Low Donald E; Eckburg Paul B; Talbot George H; Friedland H David; Lee Jon; Llorens Lily; Critchley Ian A; Thye Dirk A
Description
An account of the resource
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) \textgreater/= -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, serious AEs, deaths and discontinuations because of an AE. The most common AEs for ceftaroline fosamil-treated patients were diarrhoea, headache, insomnia and nausea, and the most common AEs for ceftriaxone-treated patients were hypokalaemia, hypertension, nausea and diarrhoea. CONCLUSIONS: Ceftaroline fosamil demonstrated high clinical cure and microbiological response rates in hospitalized patients with CAP of PORT risk class III or IV. Ceftaroline fosamil was well tolerated, with a safety profile similar to that of ceftriaxone and consistent with the cephalosporin class. In this study, ceftaroline fosamil was an effective and well-tolerated treatment option for CAP.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1093/jac/dkr096" target="_blank" rel="noreferrer noopener">10.1093/jac/dkr096</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2011
80 and over
Aged
Bacteria
Bacteria/isolation & purification
Bacterial – Drug Therapy
Bacterial/*drug therapy
Ceftriaxone – Administration and Dosage
Ceftriaxone – Adverse Effects
Ceftriaxone/administration & dosage/adverse effects
Cephalosporins – Administration and Dosage
Cephalosporins – Adverse Effects
Cephalosporins/*administration & dosage/*adverse effects
Community-Acquired Infections – Drug Therapy
Community-Acquired Infections/*drug therapy
Critchley Ian A
Department of Internal Medicine
Double-Blind Method
Double-Blind Studies
Eckburg Paul B
Female
File Thomas M Jr
Friedland H David
Human
Humans
Infusions
Intravenous
Lee Jon
Llorens Lily
Low Donald E
Male
Middle Age
Middle Aged
NEOMED College of Medicine
Pneumonia
RANDOMIZED controlled trials
Talbot George H
The Journal of antimicrobial chemotherapy
Thye Dirk A
Treatment Outcome
Treatment Outcomes
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
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
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
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
An entity responsible for making the resource available
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Date
A point or period of time associated with an event in the lifecycle of the resource
2010
2010-12
Subject
The topic of the resource
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
An entity primarily responsible for making the resource
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
An account of the resource
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
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1086/657313" target="_blank" rel="noreferrer noopener">10.1086/657313</a>
Rights
Information about rights held in and over the resource
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
-
Text
A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text.
URL Address
<a href="http://doi.org/10.1016/j.ijantimicag.2017.01.043" target="_blank" rel="noreferrer noopener">http://doi.org/10.1016/j.ijantimicag.2017.01.043</a>
Pages
247–251
Issue
2
Volume
50
Dublin Core
The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.
Title
A name given to the resource
Macrolide therapy for community-acquired pneumonia due to atypical pathogens: outcome assessment at an early time point.
Publisher
An entity responsible for making the resource available
International journal of antimicrobial agents
Date
A point or period of time associated with an event in the lifecycle of the resource
2017
2017-08
Subject
The topic of the resource
80 and over; Adult; Aged; Anti-Bacterial Agents/adverse effects/*therapeutic use; Atypical pathogen; Bacterial/*drug therapy; Ceftaroline fosamil; Ceftriaxone/adverse effects/*therapeutic use; Cephalosporins/adverse effects/*therapeutic use; Chlamydial Pneumonia; Chlamydophila pneumoniae; Clinical Trials; Combination/adverse effects/methods; Community-Acquired Infections/*drug therapy; Community-acquired pneumonia; Double-Blind Method; Drug Therapy; Female; Humans; Legionella pneumophila; Macrolide; Macrolides/adverse effects/*therapeutic use; Male; Middle Aged; Mycoplasma; Mycoplasma pneumoniae; Phase III as Topic; Pneumonia; Randomized Controlled Trials as Topic; Time Factors; Treatment Outcome
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Eckburg Paul B; Talbot George H; Llorens Lily; Friedland H David
Description
An account of the resource
BACKGROUND: Therapy directed against atypical pathogens in patients with community-acquired pneumonia (CAP) is often recommended. This post-hoc analysis evaluated the effect of addition of a macrolide to ceftaroline fosamil or ceftriaxone treatment in atypical CAP. METHODS: Two phase 3, double-blind, comparative safety and efficacy studies of ceftaroline fosamil vs. ceftriaxone, FOCUS 1 and FOCUS 2, enrolled adults with CAP. Only FOCUS 1 included 24-h adjunctive clarithromycin therapy for all patients on day 1. Day 4 and test-of-cure (TOC) outcomes were compared for adjunctive vs. no adjunctive therapy. RESULTS: Of 1240 enrolled patients, 130 patients with CAP due to atypical pathogens alone were included (FOCUS 1, n = 64; FOCUS 2, n = 66). Among patients infected with Mycoplasma pneumoniae and/or Chlamydophila pneumoniae alone, a higher clinical response rate was observed with clarithromycin plus ceftaroline fosamil or ceftriaxone compared with treatment without additional clarithromycin at day 4 [38/49 (77.6%; FOCUS 1) vs. 24/43 (55.8%; FOCUS 2)], but not at the TOC assessment [42/49 (85.7%; FOCUS 1) vs. 41/43 (95.3%; FOCUS 2)]. In patients infected with Legionella pneumophila alone, a higher clinical response rate with adjunctive clarithromycin therapy was observed at the TOC assessment alone [12/12 (100%; FOCUS 1) vs. 14/19 (73.7%; FOCUS 2)]. The unadjusted odds ratio of a favourable clinical response at day 4 with adjunctive clarithromycin vs. no adjunctive clarithromycin was 2.4 (95% confidence interval 1.1-5.1; P = 0.0299) for all pathogens combined. CONCLUSIONS: These results suggest that empirical antibiotic therapy against atypical pathogens may improve early clinical response rate. This hypothesis is best evaluated in a prospective trial.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1016/j.ijantimicag.2017.01.043" target="_blank" rel="noreferrer noopener">10.1016/j.ijantimicag.2017.01.043</a>
Rights
Information about rights held in and over the resource
Article information provided for research and reference use only. All rights are retained by the journal listed under publisher and/or the creator(s).
2017
80 and over
Adult
Aged
Anti-Bacterial Agents/adverse effects/*therapeutic use
Atypical pathogen
Bacterial/*drug therapy
Ceftaroline fosamil
Ceftriaxone/adverse effects/*therapeutic use
Cephalosporins/adverse effects/*therapeutic use
Chlamydial Pneumonia
Chlamydophila pneumoniae
Clinical Trials
Combination/adverse effects/methods
Community-Acquired Infections/*drug therapy
Community-acquired pneumonia
Department of Internal Medicine
Double-Blind Method
Drug Therapy
Eckburg Paul B
Female
File Thomas M Jr
Friedland H David
Humans
International journal of antimicrobial agents
Legionella pneumophila
Llorens Lily
Macrolide
Macrolides/adverse effects/*therapeutic use
Male
Middle Aged
Mycoplasma
Mycoplasma pneumoniae
NEOMED College of Medicine
Phase III as Topic
Pneumonia
Randomized Controlled Trials as Topic
Talbot George H
Time Factors
Treatment Outcome