Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Eritrea

World Health Organization (WHO) (Switzerland)0 个研究点目标入组 180 人开始时间: 2007年9月7日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. All ages, 6 months and above
•2. Single infection with P. falciparum
•3. Parasitaemia of 1,000 - 100, 000 asexual forms per µl
•4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C, or history of fever in the previous 24 hours
•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 from a parent or guardian in case of children

•1. Presence of general danger signs among children less than 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions
•2. Mixed or mono-infection with another Plasmodium species
•3. Presence of severe malnutrition defined as a child whose weight-for-height is below 3 Standard Deviation (SD)
•4. 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, Human Immunodeficiency Virus [HIV]/Acquired Immune Deficiency Syndrome [AIDS])
•5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment
•6. Pregnancy or positive pregnancy test or lactating

发起方

World Health Organization (WHO) (Switzerland)