针对ADAPT-TDM的研究协议:一种β-乳糖抗生素剂量适应可行性随机对照试验使用治疗药物监测
Rekha Pai Mangalore1,2, Ming Gene Chai3,4, Jeffrey Pope5
1Infectious Disease, Alfred Health, Melbourne, Victoria, Australia rekhapai16@yahoo.co.in.
BMJ open
|July 1, 2024
概括
这项研究评估了使用治疗药物监测 (TDM) 来指导危急病患者的β-乳糖抗生素剂量的可行性. 它旨在改善抗生素暴露,减少治疗失败或毒性.
科学领域:
- 药理动力学和药理动力学
- 关键护理医学 关键护理医学
- 抗生素管理的管理.
背景情况:
- 危急病患者通常因改变了影响药物药理动学的生理学而接受低于最佳的β-乳糖抗生素剂量.
- 低于最佳的抗生素度增加了治疗失败和毒性的风险.
- 治疗药物监测 (TDM) 可以个性化剂量以优化抗生素暴露,但其在重症监护病房 (ICU) 的实施尚未建立.
研究的目的:
- 评估在重症监护室 (ICU) 环境中对重症患者实施β-乳糖TDM导向剂量的可行性和可靠性.
- 评估TDM在改善抗生素暴露和患者结果方面的潜力.
- 为了收集数据进行更大规模的Beta-lactam TDMIII期试验.
主要方法:
- 一个单中心的,未盲目的,可行性随机对照试验 (ADAPT-TDM) 涉及多达60名重症成人参与者.
- 干预组每天接受TDM和对beta-lactam抗生素的剂量调整.
- 对照组接受了血采样的标准护理,但没有进行剂量调整.
主要成果:
- 主要结果集中在招聘的可行性和TDM流程的忠实性 (样本采集,处理,结果可用性).
- 二级结局包括达到目标抗生素度,采用TDM导向剂量,以及神经毒性,肝毒性和毒性等不良事件的发生率.
- 这项研究旨在确定β-乳糖TDM导向剂量调整是否可重复和可行.
结论:
- ADAPT-TDM试验将提供关于在ICU中实施β-乳糖TDM的可行性和可重复性的关键数据.
- 研究结果将为未来的III期试验的设计和执行提供信息,以优化重症患者的抗生素治疗.
- 成功实施TDM可以通过确保足够的抗生素暴露来改善患者的治疗结果.
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