Bacterial pneumonia: lefamulin vs moxifloxacin

  • Alexander E & al.
  • JAMA
  • 27 Sep 2019

  • International Clinical Digest
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Takeaway

  • Lefamulin is noninferior to moxifloxacin for oral treatment of community-acquired bacterial pneumonia (CABP); both agents achieved a 90% clinical response.

Why this matters

  • New antibacterials are needed for CABP because of growing antibacterial resistance.

Study design

  • Phase 3 LEAP 2 multicenter noninferiority randomised controlled trial (n=738), with noninferiority margin set at 10%.
  • Doses: oral lefamulin (600 mg every 12 hours for 5 days) vs moxifloxacin (400 mg every 24 hours for 7 days).
  • FDA coprimary outcome: early clinical response at 96 hours (within a 24-hour window) after first dose. 
    • Clinical response was defined as alive, showing improvement in ≥2 of the 4 CABP symptoms, having no worsening of any CABP symptom, and not receiving any nonstudy antibacterial for current CABP episode.
  • Funding: Nabriva Therapeutics.

Key results

  • Lefamulin achieved similar rates of clinical response (90.8%) to moxifloxacin (90.8%; difference, 0.1%; 1-sided 97.5% CI, −4.4% to infinity).
  • Lefamulin yielded similar rates of investigator assessment of clinical response at test of cure (coprimary outcome set by European Medicines Agency) in the modified intent-to-treat population (87.5% vs 89.1%; difference −1.6%; 1-sided 97.5% CI, −6.3% to infinity).
  • Lefamulin resulted in a higher rate of adverse events (32.6% vs 25.0%), especially gastrointestinal adverse effects.

Limitations

  • Exclusion criteria may limit generalisability.

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