PACTR201905606150545尚未招募4 期
Efficacy and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Ouesso,
Health Ministry of Congo0 个研究点目标入组 176 人开始时间: 2018年12月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
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
- 年龄范围
- 0 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. age from 6 months to 11 years;
- •2. mono-infection with P. falciparum detected by microscopy;
- •3. parasitaemia of 1000–200,000/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 patient or parent/ guardian of children.
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 < 6/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 below 115 mm)
- •6. 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);
- •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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