Efficacy and safety of artesunate and dihydroartemisinin-piparaquine (DHA-PIP) for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine in Plasmodium vivax malaria in Yunnan and Jiangsu province, China

ational Institute of Parasitic Diseases, China Center for Disease Control and Prevention0 个研究点目标入组 240 人开始时间: 2010年11月18日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•age between 6 months to 60 years old;
•- mono-infection with P. falciparum detected by microscopy with parasitaemia of 1000-100,000/ul asexual forms
•- mono-infection with P. vivax detected by microscopy with parasitaemia of more than 250/ul asexual forms
•- presence of axillary or tympanic temperature = 37.5 degrees centigrade, or oral or rectal temperature of = 38 degrees centigrade or history of fever during the past 24 hours;
•- 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.

•- 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 (defined as a child whose growth standard is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm);
•- 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;
•- unable to or unwilling to take a pregnancy test or contraceptives (for women of child-bearing age);
•unmarried women 12-18 years old;
•- G6PD deficiency for P.vivax patients.

发起方

ational Institute of Parasitic Diseases, China Center for Disease Control and Prevention