ACTRN12616000526471已完成4 期
Efficacy and safety of artesunate in treatment of malaria caused by Plasmodium falciparum parasite in Guyana
Regional Office for the Americas of the World Health Organization0 个研究点目标入组 50 人开始时间: 2016年4月22日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 2 Years 至 60 Years(—)
- 性别
- All
入选标准
- •1. age greater or equal to 2 years;
- •2. mono-infection with P. falciparum detected by microscopy;
- •3. parasitaemia of 1000–100,000/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 patients or parent or 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. mixed or mono-infection with another Plasmodium species detected by microscopy;
- •3. presence of severe malnutrition defined as a child aged 6-60 months has a mid-upper arm circumference belo 115 mm)
- •4. 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);
- •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);
- •7. a positive pregnancy test or breastfeeding (include this criterion only if adults are included);
- •8. unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age);
- •9. previous antimalarial drug intake in the past 48 hours;
- •10. Patients presenting with splenectomy.
研究者
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