Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- side effects
研究概览
简要总结
The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.
详细描述
Voriconazole is an anti-fungal agent, which is used in the treatment of invasive fungal infection, especially aspergillosis. The serious side effects of voriconazole include liver function abnormality, encephalopathy, etc. Recently, the several studies showed that the blood level of voriconazole is variable and it is associated with drug side effect and treatment outcome. However, there is no randomized controlled study which proves that therapeutic drug monitoring of voriconazole can improve the clinical outcome in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who were 16 years of age or older
- •receiving voriconazole in order to treat invasive fungal infections or for empirical use
排除标准
- •who experienced the serious side effect of voriconazole
- •were hypersensitive to azoles
- •had an aminotransferase, bilirubin, or alkaline phosphatase level higher than five times the upper limit of normal
研究组 & 干预措施
TDM of voriconazole
干预措施: Voriconazole (therapeutic drug monitoring) (Drug)
结局指标
主要结局
side effects
时间窗: during 3 months
次要结局
- treatment response to voriconazole(at 3 months)
- drug discontinuation of adverse events(within 3 month)
研究者
Wan Beom Park
Assistant Professor
Seoul National University Hospital