Programmatic Implementation of ACTs in Malawi: Safety and Effectiveness of Combination Therapies With Repeated Treatments for Uncomplicated P. Falciparum Malaria Over a Three-year Period
试验速览
- 阶段
- 4 期
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Prevalence of ototoxicity at 18 months and 36 months of enrolment.
研究概览
简要总结
A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).
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
- 4 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Artemether-lumefantrine
Children in this study arm will be treated with artemether-lumefantrine during a three year follow-up period each time a child develops uncomplicated malaria.
干预措施: Artemether-lumefantrine combination (Drug)
Dihydroartemisinin-piperaquine
Children in this study arm will be treated with dihydroartemisinin-piperaquine during a three year follow-up period each time a child develops uncomplicated malaria.
干预措施: Artemether-lumefantrine combination (Drug)
结局指标
主要结局
Prevalence of ototoxicity at 18 months and 36 months of enrolment.
时间窗: At 18 mo and 36 month of follow up
次要结局
- Incidence of clinical malaria during 18 months and 36 months of follow-up(18 and 36 months of follow up)