NCT00310505已完成不适用
Randomised Double Blind Dose Ranging Study of Amphotericin B in Visceral Leishmaniasis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,500
- 试验地点
- 2
- 主要终点
- Final cure rate at six months after the end of treatment
研究概览
简要总结
This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.
详细描述
This study is being conducted to assess the safety and efficacy of amphotericin B deoxycholate in doses of 0.75 mg/kg or 1.0 mg/kg for 15 doses. In each arm the drug is given in the conventional way every alternate day against the daily administration regimen being tested.
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
- None
入排标准
- 年龄范围
- 2 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parasitologically proved kala-azar
排除标准
- •HIV positive serology
结局指标
主要结局
Final cure rate at six months after the end of treatment
次要结局
未报告次要终点
研究者
研究点 (2)
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