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Tytuł:
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Oral 5-Day Lefamulin for Outpatient Management of Community-Acquired Bacterial Pneumonia: Post-hoc Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 Trial.
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Autorzy:
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LoVecchio F; ASU, U of AZ, Creighton, Valleywise Medical Center, University of Arizona, Phoenix, Arizona.
Schranz J; Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.
Alexander E; Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.
Mariano D; Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.
Meads A; Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania.
Sandrock C; UC Davis School of Medicine, Sacramento, California.
Moran GJ; Olive View-UCLA Medical Center, Los Angeles, California.
Giordano PA; Department of Emergency Medicine, Orlando Regional Medical Center, Orlando, Florida.
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Źródło:
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The Journal of emergency medicine [J Emerg Med] 2021 Jun; Vol. 60 (6), pp. 781-792. Date of Electronic Publication: 2021 Mar 14.
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Typ publikacji:
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Journal Article; Randomized Controlled Trial
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Język:
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English
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Imprint Name(s):
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Publication: <2010>- : New York : Elsevier
Original Publication: New York : Pergamon Press, c1983-
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MeSH Terms:
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Community-Acquired Infections*/drug therapy
Pneumonia, Bacterial*/drug therapy
Polycyclic Compounds*
Adult ; Anti-Bacterial Agents/therapeutic use ; Diterpenes ; Fluoroquinolones/pharmacology ; Fluoroquinolones/therapeutic use ; Humans ; Outpatients ; Thioglycolates
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Contributed Indexing:
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Keywords: community-acquired bacterial pneumonia; efficacy; lefamulin; moxifloxacin; outpatients
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Substance Nomenclature:
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0 (Anti-Bacterial Agents)
0 (Diterpenes)
0 (Fluoroquinolones)
0 (Polycyclic Compounds)
0 (Thioglycolates)
21904A5386 (lefamulin)
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Entry Date(s):
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Date Created: 20210318 Date Completed: 20210708 Latest Revision: 20210708
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Update Code:
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20240105
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DOI:
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10.1016/j.jemermed.2021.02.001
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PMID:
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33731270
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Background: Safe and effective oral antibiotics are needed for outpatient management of moderate to severe community-acquired bacterial pneumonia (CABP).
Objective: We describe a post-hoc analysis of adults with CABP managed as outpatients from the Lefamulin Evaluation Against Pneumonia (LEAP) 2 double-blind, noninferiority, phase 3 clinical trial.
Methods: LEAP 2 compared the efficacy and safety of oral lefamulin 600 mg every 12 h (5 days) vs. oral moxifloxacin 400 mg every 24 h (7 days) in adults (inpatients and outpatients) with Pneumonia Outcomes Research Team (PORT) risk classes II‒IV.
Results: Overall, 41% (151 of 368) of patients receiving lefamulin and 43% (159 of 368) of patients receiving moxifloxacin started treatment as outpatients-44% and 40%, respectively, were PORT risk class III/IV, and 21% in both groups had CURB-65 scores of 2‒3. Early clinical response (at 96 ± 24 h) and investigator assessment of clinical response success rates at test of cure (5‒10 days after last study drug dose) were high and similar in both groups among all (lefamulin, 91% vs. moxifloxacin, 89‒90%), PORT risk class III/IV (89‒91% vs. 88‒91%), and CURB-65 score 2‒3 (87‒90% vs. 82‒88%) outpatients. Few outpatients (lefamulin, 2.6%; moxifloxacin, 2.5%) discontinued the study drug because of treatment-emergent adverse events (TEAEs). No outpatient in the lefamulin group was hospitalized for a TEAE, compared with 5 patients (3%), including two deaths, in the moxifloxacin group.
Conclusions: These data suggest that 5 days of oral lefamulin can be given in lieu of fluoroquinolones for outpatient treatment of adults with CABP and PORT risk class III/IV or CURB-65 scores of 2‒3.
(Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)