The Correlation of Voriconazole Trough Plasma Levels With Genetic Polymorphism, Efficacy, and Safety Outcomes in Hematologic Malignancy Patients With Invasive Pulmonary Aspergillosis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Successful outcome at 12 weeks after voriconazole use
研究概览
简要总结
Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes.
Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by CYP2C19. The polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations.
However, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in Asian populations.
The purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.
详细描述
The investigators are trying to establish that routine clinical practice for voriconazole therapeutic drug monitoring can improve the efficacy and safety outcomes.
In Korean patients with hematologic malignancy, the investigators also want to propose the optimal dosing guideline of voriconazole with different genetic polymorphisms.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all items below
- •male or female ≥ 15 years of age
- •immunocompromised patients with hematologic disorders
- •patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis
排除标准
- •severe hepatic dysfunction (t.bil, AST, ALT, ALP > 5 x upper normal limit)
- •who experienced hypersensitivity to azoles
- •pregnant women
研究组 & 干预措施
1
Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
干预措施: voriconazole (Drug)
结局指标
主要结局
Successful outcome at 12 weeks after voriconazole use
时间窗: 12 weeks
Successful outcome = complete response + partial response Unsuccessful outcome = stable disease + failure of therapy + indeterminate response
次要结局
- Non-IFI (invasive fungal infection)-related mortality at 12 weeks(12 weeks)
- breakthrough IFI(12 weeks)
- Adverse drug reactions(12 weeks)
- IFI (invasive fungal infection)-related mortality at 12 weeks(12 weeks)
- Successful outcomes at various time points(1 week, 2 weeks, 4 weeks, and 8 weeks)
研究者
Sung-Han Kim
Assistantant Professor
Asan Medical Center