En Route towards European Clinical Breakpoints for Veterinary Antimicrobial Susceptibility Testing: A Position Paper Explaining the VetCAST Approach.
En Route towards European Clinical Breakpoints for Veterinary Antimicrobial Susceptibility Testing: A Position Paper Explaining the VetCAST Approach.
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DOI：
10.3389/fmicb.2017.02344
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发表时间：
2017
影响因子：
5.2
通讯作者：
Lees P
中科院分区：
文献类型：
--
作者：
Toutain PL;Bousquet-Mélou A;Damborg P;Ferran AA;Mevius D;Pelligand L;Veldman KT;Lees P
VetCAST 是 EUCAST 兽医抗菌药物敏感性测试小组委员会。其职责是确定欧洲兽药中使用的抗菌药物 (AMD) 的临床断点 (CBP)。本立场文件概述了解决动物物种、药物和疾病状况的特定 CBP 测定挑战的程序并回顾了科学选择。 VetCAST将采用EUCAST方法：第一步是数据评估；然后是 CBP 的决策程序；最后发布 CBP 实施建议。 VetCAST 预期的主要挑战是与 AMD 给药的不同方式相关的挑战，包括大规模用药、特定的长效产品配方或局部给药。具体挑战包括奶牛乳腺炎的治疗、物种范围和物种内品种考虑因素以及与人类医学无关的其他几个可变因素。每个 CBP 将基于以下考虑： (i) 流行病学临界值 (ECOFF) – 定义野生型 MIC 分布上限的最高 MIC； (ii) 从临床前药代动力学数据获得的 PK/PD 断点 [此 PK/PD 断点是目标群体中给定百分比的动物达到选定 PK/PD 指数的临界值（fAUC/MIC 或 fT > MIC）时可能达到的最高 MIC] 和 (iii) 如果可能，临床截止点，即 MIC 和临床治愈之间的关系。对于后者，VetCAST 承认兽医学中此类数据的缺乏。当无法建立 CBP 时，VetCAST 将建议使用 ECOFF 作为替代。对于决策步骤，VetCAST 将遵循 EUCAST 程序，涉及透明度、共识和独立性。 VetCAST 将确保免费传播有关标准、指南、ECOFF、PK/PD 断点、CBP 和 AST 实施的其他相关信息的信息。最后，在建立 CBP 后，VetCAST 将发布与 CBP 相关的专家意见和/或建议，以促进其在临床环境中的良好实施。
VetCAST is the EUCAST sub-committee for Veterinary Antimicrobial Susceptibility Testing. Its remit is to define clinical breakpoints (CBPs) for antimicrobial drugs (AMDs) used in veterinary medicine in Europe. This position paper outlines the procedures and reviews scientific options to solve challenges for the determination of specific CBPs for animal species, drug substances and disease conditions. VetCAST will adopt EUCAST approaches: the initial step will be data assessment; then procedures for decisions on the CBP; and finally the release of recommendations for CBP implementation. The principal challenges anticipated by VetCAST are those associated with the differing modalities of AMD administration, including mass medication, specific long-acting product formulations or local administration. Specific challenges comprise mastitis treatment in dairy cattle, the range of species and within species breed considerations and several other variable factors not relevant to human medicine. Each CBP will be based on consideration of: (i) an epidemiological cut-off value (ECOFF) – the highest MIC that defines the upper end of the wild-type MIC distribution; (ii) a PK/PD breakpoint obtained from pre-clinical pharmacokinetic data [this PK/PD break-point is the highest possible MIC for which a given percentage of animals in the target population achieves a critical value for the selected PK/PD index (fAUC/MIC or fT > MIC)] and (iii) when possible, a clinical cut-off, that is the relationship between MIC and clinical cure. For the latter, VetCAST acknowledges the paucity of such data in veterinary medicine. When a CBP cannot be established, VetCAST will recommend use of ECOFF as surrogate. For decision steps, VetCAST will follow EUCAST procedures involving transparency, consensus and independence. VetCAST will ensure freely available dissemination of information, concerning standards, guidelines, ECOFF, PK/PD breakpoints, CBPs and other relevant information for AST implementation. Finally, after establishing a CBP, VetCAST will promulgate expert comments and/or recommendations associated with CBPs to facilitate their sound implementation in a clinical setting.