ACTRN12614000217606招募中3 期
A study evaluating the efficacy and safety of artemether lumefantrine for the treatment of uncomplicated plasmodium falciparum infections in Lunglei district (Mizoram); Changlang district (Arunachal Pradesh), Gomati district or Dhalai district (Tripura) in India.
ational Insititute of Malaria Research0 个研究点目标入组 70 人开始时间: 2014年2月28日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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
- 1 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Age between 1 year to 65 years ; Mono infection with P. falciparum detected by microscopy, parasitaemia of (1000)–(100000)/microlitre asexual forms; presence of axillary great than or equal to 37.5 degrees celsius or history of fever during the past 48 h; ability to swallow oral medication; ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and informed consent from the patient or from a parent or guardian in the case of children
排除标准
- •Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of severe malnutrition, 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); regular medication, which may interfere with antimalarial pharmacokinetics; history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s); a positive pregnancy test or breastfeeding; and unable to or unwilling to take contraceptives (for women of child-bearing age).
研究者
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