Oral 5-Day Lefamulin for Outpatient Management of Community-Acquired Bacterial Pneumonia: Post-hoc Analysis of the Lefamulin Evaluation Against Pneumonia (LEAP) 2 Trial.

Abstract

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.

• Authors: Frank LoVecchio, Jennifer Schranz, Elizabeth Alexander, David Mariano, Andrew Meads, Christian Sandrock, Gregory J Moran, Philip A Giordano
• Journal: The Journal of emergency medicine (J Emerg Med) Vol. 60 Issue 6 Pg. 781-792 (Jun 2021) ISSN: 0736-4679 [Print] United States
• PMID: 33731270 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

Chemical References

• Anti-Bacterial Agents
• Diterpenes
• Fluoroquinolones
• Polycyclic Compounds
• Thioglycolates
• lefamulin

Topics

• Adult
• Anti-Bacterial Agents (therapeutic use)
• Community-Acquired Infections (drug therapy)
• Diterpenes
• Fluoroquinolones (pharmacology, therapeutic use)
• Humans
• Outpatients
• Pneumonia, Bacterial (drug therapy)
• Polycyclic Compounds
• Thioglycolates