NCT00455364终止4 期
Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Subject will be monitored for any fungal infection throughout the duration of the study.
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation.
详细描述
All participants will receive itraconazole during their inpatient post transplant stay. As an outpatient, ten subjects will be randomized to receive itraconazole 200mg orally once daily for 6 month and ten patients to receive voriconazole 200mg orally twice daily for 6 months . All subjects will be followed in the clinic as per the standard transplant treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bilateral-lung or single-lung transplant recipients between the ages of 18- 65 years old.
- •Patients must be able to give informed consent prior to and again after transplantation
排除标准
- •Lung transplant patients unable to give informed consent.
- •Prior adverse reaction to the drug itraconazole or voriconazole
结局指标
主要结局
Subject will be monitored for any fungal infection throughout the duration of the study.
次要结局
未报告次要终点
研究者
研究点 (2)
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