ACTRN12612000940875招募中未知
Efficacy and safety of artesunate/amodiaquine and Artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Brazzaville and Owando - Republic of the Congo
Ministry of Health and Population of the Republic of Congo0 个研究点目标入组 352 人开始时间: 2012年9月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 352
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 6 Months 至 10 Years（—）
- 性别
- All
入选标准
- •1. age between 6 months and 10 yeasr;
- •2. mono-infection with P. falciparum detected by microscopy;
- •3. parasitaemia of 1000-200,000/microlitre asexual forms;
- •4. presence of axillary (greater or equal to) 37.5 degrees C or history of fever during the past 24 h;
- •5. ability to swallow oral medication;
- •6. ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
- •7. informed consent from a parent or guardian of children.
排除标准
- •1. presence of general danger signs or signs of severe falciparum malaria according to the definitions of WHO;
- •2. mixed or mono-infection with another Plasmodium species detected by microscopy;
- •3. presence of severe malnutrition (defined as a child whose growth standard is below –3 (z-score), having a symmetrical oedema involving at least the feet or having a mid-upper arm circumference < 110 mm);
- •4. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- •5. regular medication, which may interfere with antimalarial pharmacokinetics;
- •6. history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s).
研究者
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