Trial reportJournal of global antimicrobial resistance2022
Pooled microbiological findings and efficacy outcomes by pathogen in adults with community-acquired bacterial pneumonia from the Lefamulin Evaluation Against Pneumonia (LEAP) 1 and LEAP 2 phase 3 trials of lefamulin versus moxifloxacin.
Trial report in Journal of global antimicrobial resistance, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Lefamulin versus omadacycline for community acquired bacterial pneumonia: a systematic review and anchored indirect treatment comparison using moxifloxacin as the common comparator.Journal of comparative effectiveness research · 2026Pooled it
- The Convergence of Antimicrobial Resistance and Virulence inMicroorganisms · 2026Review
- Performance of gradient diffusion strip and disk diffusion versus broth microdilution for lefamulin susceptibility testing of 422Journal of clinical microbiology · 2026Article
- Vancomycin resistance in gram-positive infections: evolutionary strategies of survival.Archives of microbiology · 2026Review
- Nafithromycin in CABP: promise and precaution-authors' reply.The Lancet regional health. Southeast Asia · 2025Article
- Efficacy and safety of a 3-day once-daily regimen of oral nafithromycin in comparison to oral moxifloxacin for the treatment of community-acquired bacterial pneumonia in adults: a phase III, randomized, double-blind controlled trial.The Lancet regional health. Southeast Asia · 2025Article
- Overview of changes in the Clinical and Laboratory Standards Institute Performance Standards for Antimicrobial Susceptibility Testing: M100 32nd and 33rd editions.Journal of clinical microbiology · 2025Review
- Antimicrobial activity of lefamulin against pathogens most commonly causing community-acquired pneumonia: results from the China antimicrobial surveillance network in 2020-2022.European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025Article
- In Vivo Immune-Modulatory Activity of Lefamulin in an Influenza Virus A (H1N1) Infection Model in Mice.International journal of molecular sciences · 2024Article
- The novel pleuromutilin derivative 22-((4-((4-nitrophenyl)acetamido)phenyl)thio)deoxy pleuromutilin possesses robust anti-mycoplasma activity bothFrontiers in pharmacology · 2024Article
- Current Treatment Strategies Against Multidrug-Resistant Bacteria: A Review.Current microbiology · 2022Review
- Lefamulin: a New Hope in the Field of Community-Acquired Bacterial Pneumonia.Current pharmacology reports · 2022Review
- Lefamulin in Patients with Community-Acquired Bacterial Pneumonia Caused by Atypical Respiratory Pathogens: Pooled Results from Two Phase 3 Trials.Antibiotics (Basel, Switzerland) · 2021Article
Corrections and comments
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Authors and funding
13 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesLefamulin, a pleuromutilin antibiotic approved for community-acquired bacterial pneumonia (CABP), was evaluated for microbiological efficacy in a prespecified pooled analysis of LEAP 1 and 2 phase 3 clinical trial data in patients with CABP.
methodsIn LEAP 1, adults (PORT risk class III‒V) received intravenous (IV) lefamulin 150 mg every 12 h (q12h) for 5‒7 days or moxifloxacin 400 mg every 24 h (q24h) for 7 days, with optional IV-to-oral switch. In LEAP 2, adults (PORT II‒IV) received oral lefamulin 600 mg q12h for 5 days or moxifloxacin 400 mg q24h for 7 days. Primary outcomes were early clinical response (ECR) at 96 ± 24 h after treatment start and investigator assessment of clinical response (IACR) 5‒10 days after the last dose. Secondary outcomes included ECR and IACR in patients with a baseline CABP pathogen (detected via culture, urinary antigen testing, serology and/or real-time PCR).
resultsBaseline CABP pathogens were detected in 709/1289 patients (55.0%; microbiological intention-to-treat population). The most frequently identified pathogens were Streptococcus pneumoniae (61.9% of patients) and Haemophilus influenzae (29.9%); 25.1% had atypical pathogens and 33.1% had polymicrobial infections. Pathogens were identified most frequently by PCR from sputum, followed by culture from respiratory specimens. In patients with baseline CABP pathogens, ECR rates were 89.3% (lefamulin) and 93.0% (moxifloxacin); IACR success rates were 83.2% and 86.7%, respectively. Results were consistent across CABP pathogens, including drug-resistant isolates and polymicrobial infections.
conclusionLefamulin is a valuable IV and oral monotherapy option for empirical and directed CABP treatment in adults.
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