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首页> 外文期刊>Journal of Clinical Microbiology >Determination of MIC Quality Control Parameters for Exebacase, a Novel Lysin with Antistaphylococcal Activity
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Determination of MIC Quality Control Parameters for Exebacase, a Novel Lysin with Antistaphylococcal Activity

机译:具有抗视蛋白的新型溶酶对外生物酶MIC质量控制参数的测定

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ABSTRACT Exebacase (CF-301), a novel, antistaphylococcal lysin (cell wall hydrolase) is the first agent of this class to enter late-stage clinical development (phase 3, NCT04160468) for the treatment of Staphylococcus aureus bacteremia, including right-sided endocarditis. A multilaboratory Clinical and Laboratory Standards Institute (CLSI) M23-defined tier 2 quality control (QC) study was conducted to establish exebacase QC ranges for a new reference broth microdilution method. S. aureus ATCC 29213 and Enterococcus faecalis ATCC 29212 were selected as reference QC strains. Broth microdilution MIC QC ranges for exebacase spanned 4 log _(2) dilutions and contained 99.2% of the MIC results generated for the two reference strains. The QC ranges for exebacase were defined as 0.25 to 2?μg/ml and 8 to 64?μg/ml against S. aureus ATCC 29213 and E. faecalis ATCC 29212, respectively, and were approved by the CLSI Subcommittee on Antimicrobial Susceptibility Testing. These QC ranges established for use with the reference broth microdilution method developed for exebacase susceptibility testing will ensure the test performance and accuracy of results generated during clinical development.
机译:摘要ExeBacase(CF-301),一种新型抗逆性抗视液(Cell壁水解酶)是该类的第一剂,进入后期临床发育(第3期,NCT04160468)用于治疗金黄色葡萄球菌菌血症,包括右侧心内膜炎。进行多目标临床和实验室标准研究所(CLSI)M23定义的Tier 2质量控制(QC)研究,以建立新的参考肉汤微量稀释方法的开发酶QC范围。选择Aureus ATCC 29213和肠球菌粪便ATCC 29212作为参考QC菌株。肉汤微泡麦克风QC QC QC用于跨越4个Log _(2)稀释液,并包含为两个参考菌株产生的MIC结果的99.2%。除垢酶的QC范围分别定义为0.25至2Ω·μg/ ml,分别对抗金黄色葡萄球菌ATCC 29213和E.·····瓦斯(FAECalis ATCC 29212),并经CLSI小组委员会批准对抗微生物易感性测试。建立了用于开发用于ePACase易感性测试的参考肉汤微量稀释方法的QC范围将确保临床开发期间产生的结果和准确性。

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