Pharmacokinetics, Safety and Tolerability of Single Dose Dalbavancin in Children 12-17 Years of Age
Pharmacokinetics, Safety and Tolerability of Single Dose Dalbavancin in Children 12-17 Years of Age
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DOI：
10.1097/inf.0000000000000646
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发表时间：
2015-07-01
影响因子：
3.6
通讯作者：
Sullivan, Janice E.
中科院分区：
文献类型：
--
作者：
Bradley, John S.;Puttagunta, Sailaja;Sullivan, Janice E.
背景：Dalbavancin是一种脂糖肽类抗生素，具有革兰氏阳性活性和新的药代动力学（PK）特性，可使成人的终末半衰期延长15.5天。在复杂皮肤和皮肤结构感染的成人3期研究中，每周给药一次，记录了达巴文星暴露与临床和微生物疗效相关。尚未在儿童中检测PK特性。这项开放标签、多中心单剂量1期研究的主要目的是表征达尔巴伐辛在12-17岁住院儿科受试者中的PK。方法：体重60 kg及以上的受试者单次静脉滴注达巴万辛1000 mg（成人标准剂量），每次30分钟，体重15 mg/kg
Background: Dalbavancin is a lipoglycopeptide antibiotic with Gram-positive activity and novel pharmacokinetic (PK) properties that result in a prolonged terminal half-life of 15.5 days in adults. Once weekly dosing in adults in phase 3 studies of complicated skin and skin structure infections documented dalbavancin exposures associated with clinical and microbiologic efficacy. PK properties have not been examined in children. The primary objective of this open-label, multicenter single-dose phase 1 study was to characterize the PK of dalbavancin in hospitalized pediatric subjects 12-17 years of age.Methods: A single dose of 1000 mg of dalbavancin (the standard adult dose) was administered as a 30-minute intravenous infusion to subjects weighing 60 kg or greater and 15 mg/kg for subjects weighing