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临床试验/NCT00406146
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

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

发起方
University of Ghana Medical School
申办方类型
Other

研究点 (1)

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