December 2, 2019

Background: Recently there have been some observed trends in decreasing susceptibility among Strep pneumoniae isolates to antimicrobials used to treat community acquired pneumonia (CAP) (Resistance to oral penicillin and macrolides for Strep pneumoniae & macrolides and fluoroquinolones for Staph aureus).  New antibacterials are therefore needed to treat CAP because of growing antibacterial resistance. Lefamulin is the first pleuromutilin antibiotic approved for intravenous and oral use in humans. Both the intravenous and oral formulations were approved in August 2019 by the US Food and Drug Administration (FDA) to treat CAP.  It is active against the most common CAP-causing pathogens, including bacteria resistant to other antimicrobial classes. Lefamulin Evaluation Against Pneumonia 1 (LEAP 1) [1] looked at IV Lefamulin vs IV Moxifloxacin in adult patients with moderate to severe CAP and demonstrated noninferiority in that trial.   Given those results, LEAP 2 was performed to compare oral Lefamulin to oral Moxifloxacin in adult patients with moderate to severe CAP.
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