NCT00386763已完成3 期
A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 890
- 试验地点
- 5
- 主要终点
- Proportion of patients free of parasites at day 28.
研究概览
简要总结
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.
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
- Single
入排标准
- 年龄范围
- — 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female infants and children ≤12 years of age
- •body weight of ≥5 kg and <35 kg,
- •with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite
排除标准
- •complicated malaria
- •persistent vomiting
- •malaria due to parasites other than P. falciparum
- •antimalarial treatment received in the past 2 weeks
- •known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease
结局指标
主要结局
Proportion of patients free of parasites at day 28.
次要结局
- Proportion of patients free of parasites at 7 days and at 14 days
- Time to clearance from parasites
- Time to clearance of fever
- Hematology and biochemistry parameters
- Electrocardiogram
研究者
研究点 (5)
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