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临床试验/NCT02217761
NCT02217761Unknown不适用

Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan

National Taiwan University Hospital0 个研究点目标入组 400 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
主要终点
Plasma posaconazole concentration

研究概览

简要总结

The purpose of this study is to investigate the factors influencing pharmacokinetic and pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.

详细描述

Invasive fungal infection (IFI) may cause high mortality and morbidity in immune- compromised patients. Posaconazole, a new triazole antifungal agent with broad spectrum coverage, was approved for both treatment and prophylaxis of IFIs. Previous studies have demonstrated the relationship between posaconazole plasma concentration and efficacy, thus, the importance of posaconazole therapeutic drug monitoring (TDM) was gradually accepted. However, studies found inter- and intra-individual variation between concentrations, and these phenomenons were affected greatly by GI function, food intake and concomitant medication. Furthermore, there's a lack of posaconazole TDM study in Asian population.

The study was designed to describe the prescribing pattern of posaconazole, to study the relationship between concentration and clinical outcomes/ adverse events, to identify factors that influence plasma concentration, and to evaluate whether routine TDM is needed in our institution.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving posaconazole therapy
  • Patients aged 13 years old or more

排除标准

  • No posaconazole plasma concentration available

结局指标

主要结局

Plasma posaconazole concentration

时间窗: 7-10 days after taking posaconazole

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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