ISRCTN40020296已完成未知
A phase IV randomised study to assess the tolerability of artesunate-amodiaquine (AS-AQ) (Winthrop® fixed dose combination [FDC]) and artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in Liberia
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)0 个研究点目标入组 1,000 人开始时间: 2008年10月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged greater than or equal to 6 years, either sex
- •2. Weight greater than or equal to 18 kg
- •3. Symptoms of malaria defined as fever (axillary temperature greater than or equal to 37.5°C), or history of fever in previous 48 hours
- •4. Microscopic confirmation of asexual stages of P. falciparum or mixed infection
- •5. Willingness to attend for follow-up
- •6. Signed informed consent by patient or responsible caregiver
排除标准
- •1. Pregnancy (pregnancy test to be performed in women of childbearing age)
- •2. Severe malaria
- •3. AS-AQ or AL treatment at appropriate dose or more than two doses of another antimalarial in the previous 4 weeks
- •4. Known hypersensitivity to artemisinin derivates or amodiaquine, or artemether-lumefantrine
- •5. Severe anaemia (less than 5 g/dl haemoglobin)
- •6. Concomitant febrile illness if additional medication is required other than antipyretics
研究者
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