2386. Efficacy of Lefamulin (LEF) vs. Moxifloxacin (MOX) Against Common Pathogens in Adults With Community-Acquired Bacterial Pneumonia (CABP): Results From the Phase 3 Lefamulin Evaluation Against Pneumonia (LEAP 1) Study
Abstract
Abstract Background New CABP treatments with targeted activity and improved tolerability are needed. LEF, a novel pleuromutilin antibiotic that binds to a conserved region of the bacterial ribosome, is in development for IV or oral CABP treatment. This Phase 3 clinical study evaluated the efficacy of LEF vs. MOX in adults with CABP. Methods In this multicenter, randomized, double-blind study, 551 adult patients with CABP (Patient Outcomes Research Team Risk Class ≥III) were randomized to LEF 150 mg IV Q12 hours (n = 276) or MOX 400 mg IV Q24 hours (n = 275). After 6 IV doses, qualifying patients could be switched to oral therapy. Adjunctive linezolid was given with MOX for suspected methicillin-resistant S. aureus. Primary outcomes were early clinical response (ECR) in the intent-to-treat (ITT) population (FDA endpoint), and investigator assessment of clinical response (IACR) at test of cure in the modified ITT (mITT) and clinically evaluable (CE-TOC) populations (co-primary EMA endpoints). The microITT population included all patients with a baseline CABP pathogen detected by respiratory tract or blood culture, urinary antigen test, serology, and real-time PCR from sputum, oropharyngeal and nasopharyngeal swabs. The microITT2 population included patients with a CABP pathogen detected by methods excluding PCR. Confirmatory identification and susceptibility testing of isolates, serology, and PCR were performed by a central laboratory. Results LEF was noninferior to MOX for…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 551 participants or records.
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