Efficacyandsafetyartemether-lumefantrineanddihydroartemisinin-piperaquineforthetreatmentofuncomplicated Plasmodium falciparum malaria and chloroquinefor P. vivax in Buthidaung, Rakhine State

Ministry of Health and Sports0 个研究点目标入组 150 人开始时间: 2019年11月22日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/µl asexual forms) or P. vivax detected by microscopy (parasitaemia more than equal to 250/µl asexual forms), or•presence of axillary temperature moret than or equal to 37.5 °C or history of fever during the past 24 hr, or ability to swallow oral medication, or ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule, or 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 greater than 12 years and sexually active) and from their parent or guardian if under the age of majority years.

•presence of signs of severe falciparum malaria according to the definitions of WHO,, female aged from 12 years and age of majority, weight under 5 kg, haemoglobin less than 8 g/dl, 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 less than 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), Female patients who are sexually active within the age range of 12-17 year will be excluded, 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); and a positive pregnancy test or breastfeeding, unable to or unwilling to take a pregnancy test or contraceptive (for women of child-bearing age).

发起方

Ministry of Health and Sports