NCT00445796已完成4 期
Randomised, Comparative Study of the Efficacy and Safety of Arsucam® Administered as a Single Daily Intake Versus Two Daily Intakes in the Treatment of Plasmodium Falciparum Malaria Attack
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- clinical and parasitological cure on Day 14
研究概览
简要总结
Primary Objective:
To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes.
Secondary Objective:
To compare the clinical safety of the two treatment regimens.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •weighing ≥ 10 kg
- •residing in the area covered by the investigating centre throughout the entire follow-up period
- •axillary temperature ≥ 37.5 degrees Celsius or history of fever within the previous 24 hours
- •Plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre
排除标准
- •presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic Blood Pressure < 70 mmHg in adults or < 50 in children, spontaneous bleeding, inability to sit or stand
- •serious concomitant disease
- •allergy to one of the investigational medicinal products
- •pregnant women or breast-feeding women.
- •documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.
结局指标
主要结局
clinical and parasitological cure on Day 14
Secondary: incidence and severity of adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
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