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

Journal of Global Antimicrobial Resistance

Lisa Goldberg¹  Thomas M. File, Jr²  Pritty Patel³  Gregory J. Moran⁴  Stefanie Heinrich⁵  Christian Sandrock⁶  Jorge E. Vidal⁷  Steven P. Gelone⁸  Jennifer Schranz⁹  Ken B. Waites^1,10  Susanne Paukner^1,11  Anita F. Das^1,12  Elizabeth Alexander^1,12 

[1] Corresponding author. Mailing address: Nabriva Therapeutics GmbH, Leberstrasse 20, 1110 Vienna, Austria. Tel.: [phone]. (S. Paukner).;Division of Infectious Diseases, Olive View-UCLA Medical Center, Los Angeles, CA, USA;Accelerō® Bioanalytics GmbH, Berlin, Germany;Covance Central Laboratory Services, Indianapolis, IN, USA;Das Consulting, Guerneville, CA, USA;;Department of Emergency Medicine &Department of Internal Medicine, UC Davis School of Medicine, Sacramento, CA, USA;Department of Microbiology and Immunology, University of Mississippi Medical Center, Jackson, MS, USA;Department of Pathology, University of Alabama at Birmingham, Birmingham, AL, USA;Infectious Disease Division, Summa Health, Akron, OH, USA;Nabriva Therapeutics GmbH, Vienna, Austria;Nabriva Therapeutics US, Inc., Fort Washington, PA, USA;

关键词: Lefamulin;    Moxifloxacin;    Microbiology;    Community-acquired bacterial pneumonia;    CABP;    Efficacy;   

DOI  :  

来源: DOAJ

【 摘 要 】

ABSTRACT:Objectives: Lefamulin, 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. Methods: In 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). Results: Baseline 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. Conclusion: Lefamulin is a valuable IV and oral monotherapy option for empirical and directed CABP treatment in adults.

【 授权许可】

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