Efficacy and safety of artemether+lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Tak and Ranong provinces of Thailand

Bureau of Vector-Borne Diseases0 个研究点目标入组 100 人开始时间: 2011年4月19日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Age 6 months and above;
•-Mono-infection with Plasmodium falciparum detected by microscopy
•-P. falciparum parasitaemia of 500-1000000/ul asexual forms
•-presence of axillary or tympanic temperature equal or more than 37.5C 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 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 or other known underlying chronic or severe diseases -Regular medication, which may interfere with antimalarial pharmacokinetics -history of hypersensitivity reactions or contraindications to any of the medicine being tested or used as alternative treatment -Female of child-bearing potential with ages 12-17 years old inclusive -A positive pregnancy test or breastfeeding -Unable to or unwilling to take contraceptives for pregnancy negative married women of child-bearing age

发起方

Bureau of Vector-Borne Diseases