1
40
2
-
Text
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URL Address
<a href="http://doi.org/10.1093/cid/ciz090" target="_blank" rel="noreferrer noopener">http://doi.org/10.1093/cid/ciz090</a>
Pages
1856-1867
Issue
11
Volume
69
ISSN
1537-6591 1058-4838 1058-4838
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Update Year & Number
Hospital List
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
Efficacy and Safety of Intravenous-to-oral Lefamulin, a Pleuromutilin Antibiotic, for the Treatment of Community-acquired Bacterial Pneumonia: The Phase III Lefamulin Evaluation Against Pneumonia (LEAP 1) Trial.
Publisher
An entity responsible for making the resource available
Clinical Infectious Diseases
Date
A point or period of time associated with an event in the lifecycle of the resource
2019
2019-11-13
Subject
The topic of the resource
Aged; Humans; Male; Adult; Female; Middle Aged; Double-Blind Method; Administration Intravenous; Microbial Sensitivity Tests; pneumonia; Randomized Controlled Trials as Topic; antibiotic; lefamulin; moxifloxacin; pleuromutilin; Anti-Bacterial Agents/administration & dosage/adverse effects/therapeutic use; Diterpenes/administration & dosage/adverse effects/therapeutic use; Linezolid/adverse effects/therapeutic use; Moxifloxacin/administration & dosage/adverse effects/therapeutic use; Pneumonia Bacterial/drug therapy/metabolism; Polycyclic Compounds/administration & dosage/adverse effects/therapeutic use; Thioglycolates/administration & dosage/adverse effects/therapeutic use
Creator
An entity primarily responsible for making the resource
File TM; Goldberg L; Das A; Sweeney C; Saviski J; Gelone SP; Seltzer E; Paukner S; Wicha WW; Talbot GH; Gasink LB
Description
An account of the resource
BACKGROUND: Lefamulin, a pleuromutilin antibiotic, is active against pathogens commonly causing community-acquired bacterial pneumonia (CABP). The Lefamulin Evaluation Against Pneumonia (LEAP 1) study was a global noninferiority trial to evaluate the efficacy and safety of lefamulin for the treatment of CABP. METHODS: In this double-blind study, adults with CABP of Pneumonia Outcomes Research Team risk class ≥III were randomized 1:1 to receive lefamulin at 150 mg intravenously (IV) every 12 hours or moxifloxacin at 400 mg IV every 24 hours. After 6 doses, patients could be switched to an oral study drug if prespecified improvement criteria were met. If methicillin-resistant Staphylococcus aureus was suspected, either linezolid or placebo was added to moxifloxacin or lefamulin, respectively. The US Food and Drug Administration primary endpoint was an early clinical response (ECR) 96 ± 24 hours after the first dose of the study drug in the intent-to-treat (ITT) population (noninferiority margin, 12.5%). The European Medicines Agency co-primary endpoints were an investigator assessment of clinical response (IACR) 5-10 days after the last dose of the study drug in the modified ITT (mITT) and clinically evaluable (CE) populations (noninferiority margin, 10%). RESULTS: There were 551 patients randomized (n = 276 lefamulin; n = 275 moxifloxacin). Lefamulin was noninferior to moxifloxacin for ECR (87.3% vs 90.2%, respectively; difference -2.9%, 95% confidence interval [CI] g -8.5 to 2.8) and IACR (mITT, 81.7% vs 84.2%, respectively; difference -2.6%, 95% CI -8.9 to 3.9; CE, 86.9% vs 89.4%, respectively; difference -2.5%, 95% CI -8.4 to 3.4). Rates of study drug discontinuation due to treatment-emergent adverse events were 2.9% for lefamulin and 4.4% for moxifloxacin. CONCLUSIONS: Lefamulin was noninferior to moxifloxacin for the primary efficacy endpoints and was generally safe and well tolerated. CLINICAL TRIALS REGISTRATION: NCT02559310.
Identifier
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<a href="http://doi.org/10.1093/cid/ciz090" target="_blank" rel="noreferrer noopener">10.1093/cid/ciz090</a>
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Format
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journalArticle
2019
Administration Intravenous
Adult
Aged
Anti-Bacterial Agents/administration & dosage/adverse effects/therapeutic use
antibiotic
Clinical Infectious Diseases
Das A
Diterpenes/administration & dosage/adverse effects/therapeutic use
Double-Blind Method
Female
File TM
Gasink LB
Gelone SP
Goldberg L
Hospital List
Humans
journalArticle
lefamulin
Linezolid/adverse effects/therapeutic use
Male
Microbial Sensitivity Tests
Middle Aged
Moxifloxacin
Moxifloxacin/administration & dosage/adverse effects/therapeutic use
Paukner S
pleuromutilin
Pneumonia
Pneumonia Bacterial/drug therapy/metabolism
Polycyclic Compounds/administration & dosage/adverse effects/therapeutic use
Randomized Controlled Trials as Topic
Saviski J
Seltzer E
Sweeney C
Talbot GH
Thioglycolates/administration & dosage/adverse effects/therapeutic use
Wicha WW
-
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/ciw490" target="_blank" rel="noreferrer noopener">http://doi.org/10.1093/cid/ciw490</a>
Pages
1007–1016
Issue
8
Volume
63
Dublin Core
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Title
A name given to the resource
SOLITAIRE-IV: A Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous-to-Oral Solithromycin to Intravenous-to-Oral Moxifloxacin for Treatment of Community-Acquired Bacterial 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
2016
2016-10
Subject
The topic of the resource
*clinical trial; *community-acquired; *pneumonia; *solithromycin; *Streptococcus pneumoniae; 80 and over; Administration; Adult; Aged; Anti-Bacterial Agents/*administration & dosage/adverse effects; Bacterial; Bacterial/diagnosis/*drug therapy/*microbiology; Community-Acquired Infections/diagnosis/*drug therapy/*microbiology; Comorbidity; Drug Resistance; Female; Fluoroquinolones/*administration & dosage/adverse effects; Humans; Intravenous; Macrolides/*administration & dosage/adverse effects; Male; Microbial Sensitivity Tests; Middle Aged; Moxifloxacin; Oral; Pneumonia; Treatment Outcome; Triazoles/*administration & dosage/adverse effects
Creator
An entity primarily responsible for making the resource
File Thomas M Jr; Rewerska Barbara; Vucinic-Mihailovic Violeta; Gonong Joven Roque V; Das Anita F; Keedy Kara; Taylor David; Sheets Amanda; Fernandes Prabhavathi; Oldach David; Jamieson Brian D
Description
An account of the resource
BACKGROUND: Solithromycin, a novel macrolide antibiotic with both intravenous and oral formulations dosed once daily, has completed 2 global phase 3 trials for treatment of community-acquired bacterial pneumonia. METHODS: A total of 863 adults with community-acquired bacterial pneumonia (Pneumonia Outcomes Research Team [PORT] class II-IV) were randomized 1:1 to receive either intravenous-to-oral solithromycin or moxifloxacin for 7 once-daily doses. All patients received 400 mg intravenously on day 1 and were permitted to switch to oral dosing when clinically indicated. The primary objective was to demonstrate noninferiority (10% margin) of solithromycin to moxifloxacin in achievement of early clinical response (ECR) assessed 3 days after first dose in the intent-to-treat (ITT) population. Secondary endpoints included demonstrating noninferiority in ECR in the microbiological ITT population (micro-ITT) and determination of investigator-assessed success rates at the short-term follow-up (SFU) visit 5-10 days posttherapy. RESULTS: In the ITT population, 79.3% of solithromycin patients and 79.7% of moxifloxacin patients achieved ECR (treatment difference, -0.46; 95% confidence interval [CI], -6.1 to 5.2). In the micro-ITT population, 80.3% of solithromycin patients and 79.1% of moxifloxacin patients achieved ECR (treatment difference, 1.26; 95% CI, -8.1 to 10.6). In the ITT population, 84.6% of solithromycin patients and 88.6% of moxifloxacin patients achieved clinical success at SFU based on investigator assessment. Mostly mild/moderate infusion events led to higher incidence of adverse events overall in the solithromycin group. Other adverse events were comparable between treatment groups. CONCLUSIONS: Intravenous-to-oral solithromycin was noninferior to intravenous-to-oral moxifloxacin. Solithromycin has potential to provide an intravenous and oral option for monotherapy for community-acquired bacterial pneumonia. CLINICAL TRIALS REGISTRATION: NCT01968733.
Identifier
An unambiguous reference to the resource within a given context
<a href="http://doi.org/10.1093/cid/ciw490" target="_blank" rel="noreferrer noopener">10.1093/cid/ciw490</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).
*clinical trial
*Community-acquired
*Pneumonia
*solithromycin
*Streptococcus pneumoniae
2016
80 and over
Administration
Adult
Aged
Anti-Bacterial Agents/*administration & dosage/adverse effects
Bacterial
Bacterial/diagnosis/*drug therapy/*microbiology
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
Community-Acquired Infections/diagnosis/*drug therapy/*microbiology
Comorbidity
Das Anita F
Department of Internal Medicine
Drug Resistance
Female
Fernandes Prabhavathi
File Thomas M Jr
Fluoroquinolones/*administration & dosage/adverse effects
Gonong Joven Roque V
Humans
Intravenous
Jamieson Brian D
Keedy Kara
Macrolides/*administration & dosage/adverse effects
Male
Microbial Sensitivity Tests
Middle Aged
Moxifloxacin
NEOMED College of Medicine
Oldach David
Oral
Pneumonia
Rewerska Barbara
Sheets Amanda
Taylor David
Treatment Outcome
Triazoles/*administration & dosage/adverse effects
Vucinic-Mihailovic Violeta