ISRCTN88705995已完成不适用
A randomised open label study to assess the safety and efficacy of dihydroartemisinin-piperaquine (Artekin™) compared with lumefantrine-artemether (Coartem®) for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children
niversity of Heidelberg School of Medicine (Germany)0 个研究点目标入组 500 人开始时间: 2008年7月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
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. Males and females aged between 6 months and 59 months inclusive
- •2. Body weight of 5 kg and above
- •3. Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia greater than or equal to 2,000/µL to 200,000/µL)
- •4. History of fever in the previous 24 hours or presence of fever (axillary temperature at greater than or equal to 37.5°C)
- •5. Signed informed consent by the parents or guardians
- •6. Parents? or guardians? willingness and ability to comply with the study protocol for the duration of the trial
排除标准
- •1. Participation in any investigational drug study during the previous 30 days
- •2. Known hypersensitivity to the study drugs
- •3. Severe malaria
- •4. Danger signs: not able to drink or breast-feed, vomiting (greater than twice in 24 hours), recent history of convulsions (greater than one in 24 hours), unconscious state, unable to sit or stand
- •5. Electrocardiogram (ECG) abnormality that requires urgent management
- •6. Presence of intercurrent illness or any condition which in the judgment of the investigator would place the subject at undue risk or interfere with the results of the study
- •7. Severe malnutrition (defined as weight for height less than 70% of the median National Center for Health Statistics [NCHS]/World Health Organisation [WHO] reference)
研究者
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