Efficacy and safety of artesunate tablet and drug combination (dihydroartemisinin – piperaquine) for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for vivax malaria in 5 sentinel sites (Binh Phuoc, Dak Nong, Gia Lai, Ninh Thuan and Quang Tri provinces), Viet Nam in 2008 and 2009

Ministry of Health0 个研究点目标入组 500 人开始时间: 2011年2月15日最近更新: 2020年1月13日

适应症

试验速览

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•Adults and children over 6 months old;
•- single Infection with P. falciparum;
•- Parasitaemia: 1 000–200 000 asexual forms per micro ml of blood;
•- Presence of axillary temperature greater than or eqqual 37.5 degrees Centigrade or history of fever within the previous 24 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;
•- Informed consent from the patient or from a parent or guardian in case of children.

•- Presence of general danger signs among children <5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions.
•- Mixed or mono-infection with another Plasmodium species;
•- Presence of severe malnutrition
•- Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);
•- History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment;
•- Positive pregnancy test or lactating

发起方