1
40
2
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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/cid/cis559" target="_blank" rel="noreferrer noopener">http://doi.org/10.1093/cid/cis559</a>
Pages
S173–180
Volume
55 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
Summary of ceftaroline fosamil clinical trial studies and clinical safety.
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
2012
2012-09
Subject
The topic of the resource
Anti-Bacterial Agents/adverse effects/*therapeutic use; Bacterial/drug therapy; Cephalosporins/adverse effects/*therapeutic use; Clinical Trials as Topic; Humans; Pneumonia; Staphylococcal Skin Infections/drug therapy
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Wilcox Mark H; Stein Gary E
Description
An account of the resource
In October 2010, the new cephalosporin, ceftaroline fosamil, was approved by the US Food and Drug Administration for therapy of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSIs). The active metabolite, ceftaroline, demonstrates in vitro activity against typical bacterial pathogens most often associated with CABP or ABSSSIs, including resistant Gram-positive pathogens such as multidrug-resistant Streptococcus pneumoniae and methicillin-resistant Staphylococcus aureus. The efficacy and safety of ceftaroline fosamil was assessed in 2 large phase 3 programs of randomized, double-blind, clinical trials for CABP and ABSSSIs. For both indications, therapy with ceftaroline fosamil was observed to be noninferior to the comparator agents (ceftriaxone for CABP and vancomycin plus aztreonam for ABSSSIs) at both a standard test of cure assessment time (8-15 days after discontinuation of study drug) and an early assessment time point (day 3 or 4 of study). In the integrated analysis of the trials for CABP (FOCUS 1 and 2), clinical cure rates for the ceftaroline group were numerically higher than those for the ceftriaxone group (for the clinically evaluable population 84.3% vs 77.7%; difference: 6.6%; 95% confidence interval, 1.6%-11.8%). Among patients with CABP caused by S. pneumoniae, clinical cure rates were markedly higher in the ceftaroline treatment group than in the ceftriaxone treatment group (59 of 69 [85.5%] vs 48 of 70 [68.6%], respectively). For the ABSSSI studies (CANVAS 1 and 2), microbiologically evaluable (ME) success rates were similar between the treatment groups. Notably, the clinical cure rates in ME patients with methicillin-resistant S. aureus ABSSSIs were 142 of 152 (93.4%) and 115 of 122 (94.3%), for ceftaroline and vancomycin plus aztreonam, respectively, and did not differ from those achieved in infections due to methicillin-susceptible S. aureus (93.0%-94.5%). Ceftaroline fosamil was well tolerated, with a safety profile similar to the comparator agents used in these phase 3 trials.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1093/cid/cis559" target="_blank" rel="noreferrer noopener">10.1093/cid/cis559</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).
2012
Anti-Bacterial Agents/adverse effects/*therapeutic use
Bacterial/drug therapy
Cephalosporins/adverse effects/*therapeutic use
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Clinical Trials as Topic
Department of Internal Medicine
File Thomas M Jr
Humans
NEOMED College of Medicine
Pneumonia
Staphylococcal Skin Infections/drug therapy
Stein Gary E
Wilcox Mark H
-
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
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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