CHEST 2019 — Delafloxacin noninferior to moxifloxacin for community-acquired bacterial pneumonia


  • Keren Landman, MD
  • Conference Reports
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Takeaway

  • In the treatment of community-acquired bacterial pneumonia (CABP), delafloxacin had comparable outcomes to moxifloxacin regardless of subgroup or pathogen.

Why this matters

  • Delafloxacin has no QT restrictions, phototoxicity, food restrictions, or major drug-drug interactions.

Study design

  • 860 patients randomly assigned 1:1 in a double-blind, active-controlled phase 3 study comparing delafloxacin to moxifloxacin in patients with CABP.
  • All patients were treated for a mean 8.5 days (6.3 days intravenous, 2.2 days oral).
  • Early clinical response was assessed 96±24 hours after first dose.
  • Outcomes analyzed by subgroups including age, sex, risk factor, and bacterial pathogen.
  • Funding: Melinta Therapeutics.

Key results

  • Delafloxacin and moxifloxacin arms had similar demographics and were predominantly male and white, with 13%-14% having a history of COPD/asthma.
  • Response rates in delafloxacin (383/431) and moxifloxacin (381/428) arms were not significantly different.
    • Response rate difference of −0.2 slightly favored moxifloxacin (95% CI, −4.4 to 4.1).
  • More adverse events occurred in delafloxacin arm (30.5% vs 26.2%).
    • Most common adverse events (AEs) were diarrhea, increased transaminase, and headache.
    • Delafloxacin arm had higher rates of AEs leading to drug discontinuation (3.5% vs 1.6%).
  • Outcomes were consistent regardless of subgroup or pathogen identified.

Limitations

  • Results may not be generalizable to all demographics.