Efficacy and safety of pyronaridine-artesunate for Plasmodium vivax in Kawthaung –Mawhtaung, Tanintharyi Region and KyaInSeikgyi-Myawaddy, Kayin State in Myanmar.

Ministry of Health and Sports0 个研究点目标入组 140 人开始时间: 2018年10月2日最近更新: 2019年9月16日

适应症

试验速览

暂无简介。

•patients aged 6 year and above
•mono-infection with P. vivax detected by microscopy (parasitaemia > 250/µl asexual forms);
•presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 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 the case of children aged less than age of majority;
•informed assent from any minor participant aged from 12 to age of majority years; and
•consent for pregnancy testing from female of child-bearing age(defined as age > 17 years and sexually active).

•presence signs of severe falciparum malaria according to the definitions of WHO
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•female aged from 12 and 17 years;
•Body weight under 20 kg;
•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 pregnancy test or to use contraception for women of child-bearing age(defined as age > 12 years and sexually active).

发起方

Ministry of Health and Sports