ACTRN12616001423404已完成4 期
Evaluation of therapeutic efficacy and safety of artesunate-amodiaquine, artemether-lumefantrine and dihydroartemisinine-piperaquine for the treatment of uncomplicated Plasmodium falciparum in Democratic Republic of Congo
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 534
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 59 Months（—）
- 性别
- All
入选标准
- •1. age between six to 59 months;
- •2. mono-infection with P. falciparum detected by microscopy;
- •3. parasitaemia of 2000–200,000/microliter asexual forms;
- •4. presence of axillary temperature 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;
- •7. informed consent from the parent or guardian.
排除标准
- •1. presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
- •2. weight under 5 kg;
- •3. Haemoglobin < 8g/dl;
- •4. mixed or mono-infection with another Plasmodium species detected by microscopy;
- •5. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference belo 115 mm)
- •6. presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- •7. regular medication, which may interfere with antimalarial pharmacokinetics;
- •8. 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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