ArticleAntimicrobial agents and chemotherapy2013
Monte Carlo simulations based on phase 1 studies predict target attainment of ceftobiprole in nosocomial pneumonia patients: a validation study.
Article in Antimicrobial agents and chemotherapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 31 citations in OpenAlex.
- Pharmacokinetics and Target Attainment of Ceftobiprole in Asian and Non-Asian Subjects.Clinical pharmacology in drug development · 2018Trial
- Ceftolozane/tazobactam pharmacokinetic/pharmacodynamic-derived dose justification for phase 3 studies in patients with nosocomial pneumonia.Journal of clinical pharmacology · 2016Trial
- A phase 3 randomized double-blind comparison of ceftobiprole medocaril versus ceftazidime plus linezolid for the treatment of hospital-acquired pneumonia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014Trial
- Exposure to ceftobiprole is associated with microbiological eradication and clinical cure in patients with nosocomial pneumonia.Antimicrobial agents and chemotherapy · 2014Trial
- Population Pharmacokinetic and Pharmacodynamic Analysis for Maximizing the Effectiveness of Ceftobiprole in the Treatment of Severe Methicillin-Resistant Staphylococcal Infections.Microorganisms · 2023Article
- Model-Based Approach for Optimizing Ceftobiprole Dosage in Pediatric Patients.Antimicrobial agents and chemotherapy · 2021Article
- Pharmacokinetics, pharmacodynamics, and safety of single- and multiple-dose intravenous ceftobiprole in healthy Chinese participants.Annals of translational medicine · 2021Article
- Ceftobiprole: pharmacokinetics and PK/PD profile.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019Review
- Mechanisms of action and antimicrobial activity of ceftobiprole.Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2019Review
- Technologies to address antimicrobial resistance.Proceedings of the National Academy of Sciences of the United States of America · 2018Article
- Pharmacokinetics and Dosing of Ceftobiprole Medocaril for the Treatment of Hospital- and Community-Acquired Pneumonia in Different Patient Populations.Clinical pharmacokinetics · 2016Review
- Evaluating In Vivo-In Vitro Correlation Using a Bayesian Approach.The AAPS journal · 2016Article
- Ceftobiprole medocaril: a review of its use in patients with hospital- or community-acquired pneumonia.Drugs · 2014Review
- Individualised antibiotic dosing for patients who are critically ill: challenges and potential solutions.The Lancet. Infectious diseases · 2014Review
- Rationale for eliminating Staphylococcus breakpoints for β-lactam agents other than penicillin, oxacillin or cefoxitin, and ceftaroline.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2014Article
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Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Monte Carlo simulation (MCS) of antimicrobial dosage regimens during drug development to derive predicted target attainment values is frequently used to choose the optimal dose for the treatment of patients in phase 2 and 3 studies. A criticism is that pharmacokinetic (PK) parameter estimates and variability in healthy volunteers are smaller than those in patients. In this study, the initial estimates of exposure from MCS were compared with actual exposure data in patients treated with ceftobiprole in a phase 3 nosocomial-pneumonia (NP) study (NTC00210964). Results of MCS using population PK data from ceftobiprole derived from 12 healthy volunteers were used (J. W. Mouton, A. Schmitt-Hoffmann, S. Shapiro, N. Nashed, N. C. Punt, Antimicrob. Agents Chemother. 48:1713-1718, 2004). Actual individual exposures in patients were derived after building a population pharmacokinetic model and were used to calculate the individual exposure to ceftobiprole (the percentage of time the unbound concentration exceeds the MIC [percent fT > MIC]) for a range of MIC values. For the ranges of percent fT > MIC used to determine the dosage schedule in the phase 3 NP study, the MCS using data from a single phase 1 study in healthy volunteers accurately predicted the actual clinical exposure to ceftobiprole. The difference at 50% fT > MIC at an MIC of 4 mg/liter was 3.5% for PK-sampled patients. For higher values of percent fT > MIC and MICs, the MCS slightly underestimated the target attainment, probably due to extreme values in the PK profile distribution used in the simulations. The probability of target attainment based on MCS in healthy volunteers adequately predicted the actual exposures in a patient population, including severely ill patients.
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