NCT00329134已完成2 期
Investigation of the Efficacy of Quinine Sulphate Administered Via Taste-Masked Pellets to Children With Falciparum Malaria
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Clocktime when child has had no fever for minimal 48h (< 37,5°C)
研究概览
简要总结
No pediatric formulations of quinine exist. Therefore, quinine tablets are broken into 2 or 4 parts, according to the body weight. Based on the body weight, 1/2 or 1/4 a tablet is administered to the child.
At this moment, quinine sulphate pellets are developed. These pellets enable an adequate dosing according to the body weight.
56 children with malaria will be dosed every 8 hours during 7 days with 10-15mg/kg body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malaria (falciparium malaria, uncomplicated)
- •Informed consent
排除标准
- 未提供
结局指标
主要结局
Clocktime when child has had no fever for minimal 48h (< 37,5°C)
Parasitemy
次要结局
- Plasma concentration of quinine at day 4 between first and second administration
研究者
研究点 (1)
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