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临床试验/NCT04502355
NCT04502355Unknown不适用

Voriconazole-Induced QT Interval Prolongation: A Prospective Study

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年10月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
QT interval prolongation

研究概览

简要总结

The antifungal voriconazole is effective for the treatment of invasive fungal infections in immunocompromised patients. A serious adverse reaction is QT interval prolongation, which may precede life-threatening arrhythmias, such as torsades de pointes. Although ventricular arrhythmias are mentioned as a possible adverse effect of voriconazole, thus far, the incidence and clear recommendations for QT follow-up have not been published. This prospective observational study aimed at describing the incidence of voriconazole induced- QT interval prolongation in the pediatric population and determine the risk factors for this phenomenon.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • oral or IV treatment with voriconazole

排除标准

  • No data prior to initiation of voriconazole treatment on QT interval (baseline ECG)
  • Renal insufficiency or dialysis treatment

结局指标

主要结局

QT interval prolongation

时间窗: up to three months of treatment

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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