In community-acquired bacterial pneumonia, lefamulin was noninferior to moxifloxacin at 96 h after the first dose
Question: In patients with community-acquired bacterial pneumonia (CABP), is oral lefamulin twice daily for 5 days noninferior to oral moxifloxacin once daily for 7 days?
Design: Randomized placebo-controlled trial (Lefamulin Evaluation Against Pneumonia 2 [LEAP 2]).
Blinding: Allocation concealed; blinded (patients, study personnel, and sponsor).*
Setting: 99 clinical centers in 19 countries.
Patients: 738 adults (mean age 58 y, 52% men) who had radiographically documented pneumonia (Pneumonia Outcomes Research Team risk class II, III, or IV); acute illness (≥ 7 d); and ≥ 3 cardinal symptoms of CABP (dyspnea, new or increased cough, purulent sputum production, and chest pain). Key exclusions: > 1 dose of a short-acting antibacterial for CABP in the 72 hours before randomization, ≥ 2-day hospitalization in the past 90 days, confirmed or suspected methicillin-resistant Staphylococcus aureus, high risk for major cardiac events or dysfunction, or hepatic disease.
Interventions: Oral lefamulin, 600 mg twice daily for 5 days, plus placebo (n = 370) or oral moxifloxacin, 400 mg once daily for 7 days, plus placebo (n = 368).
Funding: Nabriva Therapeutics.