NCT00406146Unknown3 期
Amodiaquine+Artesunate vs. Artemether-Lumefantrine for Uncomplicated Malaria in Ghanaian Children
University of Ghana Medical School1 个研究点 分布在 1 个国家开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 1
研究概览
简要总结
Artemisinin combination therapies (ACT) are currently recommended for malaria treatment. Artemether-lumefantrine(A-L) and Artesunate+amodiaquine (A+A) have been the most commonly adopted of the recommended ACT regimens. In Ghana, A+A is the current first-line antimalarial treatment in Ghana, but there has been 1 efficacy report of this regimen in Ghana till date. Moreover, the safety of repeated treatments with ACT has been little studied. This study aims to evaluate the efficacy of A+A vs. A-L, as well as the safety of repeated treatments of these regimens in a longitudinal trial in which recruited children will be followed up for 1 year.
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
- 6 Months 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •microscopically confirmed acute uncomplicated falciparum malaria;
- •temperature at screening 37.50C or more or history of fever 24 preceding enrollment;
- •willingness to comply with follow up schedule;
- •written informed consent by accompanying parent or guardian
排除标准
- •features of severe malaria or danger signs of malaria
- •known intolerance or allergy to any of the study medications
- •known treatment with any of the study medications in the month preceding enrollment
- •serious underlying disease that may mask outcome assessment
研究者
研究点 (1)
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