NCT00709969已完成3 期
Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria
适应症
干预措施
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
- 310
- 试验地点
- 3
- 主要终点
- Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations
研究概览
简要总结
This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •male or female weighing ≥ 5kg and ≤ 25kg
- •P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3
- •with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite
排除标准
- •complicated malaria
- •ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks
- •severe anaemia
- •severe malnutrition
- •malaria due to other than P. falciparum
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
Artemether-lumefantrine
干预措施: Artemether-lumefantrine (Drug)
结局指标
主要结局
Adverse events, SAEs; hematology and biochemistry parameters; electrocardiogram; urine values; vital signs; physical neurological examinations; and neurological examinations
时间窗: 28 days
次要结局
- Proportion of patients free of parasites at 7, 14 and at 28 days
- Time to clearance of fever
- Time to clearance from parasites (asexual forms)
- Time to clearance of gametocytes (parasite sexual forms)
研究者
研究点 (3)
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