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40
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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
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Title
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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
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Clinical Infectious Diseases
Date
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2019
2019-11-13
Subject
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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
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File TM; Goldberg L; Das A; Sweeney C; Saviski J; Gelone SP; Seltzer E; Paukner S; Wicha WW; Talbot GH; Gasink LB
Description
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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