Assessment of the Public Health Benefit of Artemisinine Based Combination Therapies for Uncomplicated Malaria Treatment in Mali
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 780
- 试验地点
- 1
- 主要终点
- Clinical and parasitological cure rate
研究概览
简要总结
Test the hypothesis that repeated administration of Artesunate/Amiodaquine, Artesunate/Sulfadoxine-Pyrimethamine and Arthemeter-Lufemantrine for the treatment of consecutive episodes of uncomplicated malaria reduces the incidence of uncomplicated falciparum malaria and malaria attributable anemia
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight > 5kg
- •Residence in the investigator site area for the duration of the trial
- •Axillary temperature ≥ 37,5°C at Day 0
- •Confirmed Plasmodium falciparum infection,with parasitemia range from 2000 to 200000 asexual parasites /µl of blood
排除标准
- •Danger signs or signs of severe malaria
- •Other severe illnesses
- •Allergy to one of the drugs
- •Pregnant women
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Arsucam® (AS 50mg/Aq153mg),oad, per os, 3 days of treatment
干预措施: Artesunate (Drug)
2
Arsumax (AS 50mg) + Sulfadoxine-Pyrimethamine (SP=SDX 500mg/PYR 25mg), oad, per os
干预措施: Artesunate + Sulfadoxine-Pyrimethamine (Drug)
3
Coartem (arthemether 20mg+ lumefantrine 120 mg), bid, per os. Duration of treatment: 3 days
干预措施: arthemether + lumefantrine (Drug)
结局指标
主要结局
Clinical and parasitological cure rate
时间窗: at day 28
Clinical and biological tolerability
时间窗: During the study period
次要结局
未报告次要终点