CTRI/2017/11/010703已完成未知
Monitoring the therapeutic efficacy of antimalarial medicines across International borders of India.
WHO GMP0 个研究点目标入组 225 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 225
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
入选标准
- •1 age between 1 year to 65 years
- •2 Mono infection with P. falciparum detected by microscopy
- •3 asexual forms parasitaemia of 1000 to 100000 per microlitre of blood
- •4 presence of axillary temperature equal and more than 37 5 Centigrade or history of fever during the past 48 hours
- •5 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
- •6 informed consent from the patient or from a parent or guardian in the case 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
- •4 presence of febrile conditions due to diseases other than malaria eg measles acute lower respiratory tract infection severe diarrhoea with dehydration or other known underlying chronic or severe diseases eg cardiac renal and hepatic diseases HIV AID
- •5 regular medication which may interfere with antimalarial pharmacokinetics
- •6 history of hypersensitivity reactions or contraindications to any of the medicines being tested or used as alternative treatments
- •7 a positive pregnancy test or breastfeeding
- •unable to or unwilling to take contraceptives for women of child-bearing age
- •8 Minor girls aged less than 18 years who have achieved menarche
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