ArticleThe Journal of antimicrobial chemotherapy2019
Pharmacokinetic/pharmacodynamic target attainment analyses to support intravenous and oral lefamulin dose selection for the treatment of patients with community-acquired bacterial pneumonia.
Article in The Journal of antimicrobial chemotherapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- In vivo studies on antibiotic combination for the treatment of carbapenem-resistant Gram-negative bacteria: a systematic review and meta-analysis protocol.BMJ open science · 2020Pooled it
- Pharmacokinetics and tolerability of lefamulin following intravenous and oral dosing.The Journal of antimicrobial chemotherapy · 2019Trial
- One Health Perspective of Mycoplasmas: Proposals for Standardizing In Vitro PK/PD Models of Human Mycoplasma Species by Referencing Veterinary Experiences.Microorganisms · 2026Review
- Pulmonary Pharmacokinetics/Pharmacodynamics of Commonly Used Antibiotics in the Treatment of Community-Acquired Pneumonia.European journal of drug metabolism and pharmacokinetics · 2026Review
- Lefamulin harbors promising anti-tuberculosis activity against multidrug-resistantMicrobiology spectrum · 2025Article
- Pharmacokinetic/pharmacodynamic analysis of sulbactam againstJAC-antimicrobial resistance · 2024Article
- Target attainment of intravenous lefamulin for treatment of acute bacterial skin and skin structure infections.The Journal of antimicrobial chemotherapy · 2024Article
- Lefamulin dosing optimization using population pharmacokinetic and pharmacokinetic/pharmacodynamic assessment in Chinese patients with community-acquired bacterial pneumonia.Frontiers in pharmacology · 2024Article
- A Comprehensive Overview of the Antibiotics Approved in the Last Two Decades: Retrospects and Prospects.Molecules (Basel, Switzerland) · 2023Review
- In vitro susceptibility of common bacterial pathogens causing respiratory tract infections in Canada to lefamulin, a new pleuromutilin.Journal of the Association of Medical Microbiology and Infectious Disease Canada = Journal officiel de l'Association pour la microbiologie medicale et l'infectiologie Canada · 2021Article
- Model-Informed Drug Development for Anti-Infectives: State of the Art and Future.Clinical pharmacology and therapeutics · 2021Review
- Treatment of Community-Acquired Pneumonia: A Focus on Lefamulin.Infectious diseases and therapy · 2021Review
- Review
- Clinical Utility of Lefamulin: If Not Now, When?Current infectious disease reports · 2020Review
- Leave it to Lefamulin: A Pleuromutilin Treatment Option in Community-Acquired Bacterial Pneumonia.Drugs · 2019Review
- Antibacterial Activity of Lefamulin against Pathogens Most Commonly Causing Community-Acquired Bacterial Pneumonia: SENTRY Antimicrobial Surveillance Program (2015-2016).Antimicrobial agents and chemotherapy · 2019Article
- Introduction: lefamulin and pharmacokinetic/pharmacodynamic rationale to support the dose selection of lefamulin.The Journal of antimicrobial chemotherapy · 2019Article
- Pharmacokinetics/pharmacodynamics of lefamulin in a neutropenic murine pneumonia model with Staphylococcus aureus and Streptococcus pneumoniae.The Journal of antimicrobial chemotherapy · 2019Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesLefamulin is a semi-synthetic intravenous (iv) and oral pleuromutilin antibiotic active against community-acquired bacterial pneumonia (CABP) pathogens. Pharmacokinetic/pharmacodynamic (PK/PD) target attainment analyses were carried out to evaluate lefamulin 150 mg iv q12h and 600 mg orally q12h under fed and fasted conditions for the treatment of patients with CABP.
methodsThe analyses undertaken used a population PK model based on Phase 1 PK data, non-clinical PK/PD targets for efficacy and in vitro surveillance data for Streptococcus pneumoniae (SP) and Staphylococcus aureus (SA), and Monte Carlo simulation. Percentage probabilities of PK/PD target attainment by MIC on day 1 were determined using median total-drug epithelial lining fluid (ELF) and free-drug plasma AUC:MIC ratio targets associated with 1 and 2 log10 cfu reductions from baseline.
resultsPercentage probabilities of attaining the total-drug ELF AUC:MIC ratio target for a 1 log10 cfu reduction from baseline for SP were ≥99.2% at the MIC90 of 0.12 mg/L and 96.7%, 82.1% and 96.3% for iv and oral dosing regimens under fed and fasted conditions, respectively, at the MIC99 of 0.25 mg/L. Percentage probabilities of attaining the free-drug plasma AUC:MIC target for the same endpoint at the SP MIC99 were 100% for each regimen. For the SA MIC90 of 0.12 mg/L and AUC:MIC ratio targets for the same endpoint, percentage probabilities were 92.7%-100% for iv and oral dosing regimens.
conclusionsThese data provide support for lefamulin 150 mg iv q12h and 600 mg orally q12h for the treatment of patients with CABP and suggest that doses may not need to be taken under fasted conditions.
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