Efficacy and safety of artemether-lumefantrine (AL) combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria in 4 Tribal dominating states in India: Madhya Pradesh, Maharashtra, Chhattisgarh and Odisha

Indian Council of Medical Research, (ICMR) Ministry of Health & Family welfare.0 个研究点目标入组 352 人开始时间: 2016年10月24日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1.age over 6 months to 60 years old
•2.mono-infection with P. falciparum detected by microscopy;
•3.parasitaemia of 500–100,000/micro liter asexual forms;
•4.presence of axillary or tympanic temperature greater than or equal 37.5 degrees centigrade or history of fever during the past 24 h;
•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 the case of children aged less than 18 years;
•8.informed assent from any minor participant aged from 12 years to less than 18 years; and
•9.consent for pregnancy testing from female of child-bearing potential of 18 years and above.

•1.presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO;
•2.weight under 5 kg;
•3.mixed or mono-infection with another Plasmodium species detected by microscopy;
•4.presence of severe malnutrition (defined as a child aged 6-60 months whose weight-for-height is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference <115 mm).
•5.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);
•6.regular medication, which may interfere with antimalarial pharmacokinetics;
•7.history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
•8.a positive pregnancy test or breastfeeding;
•9.unable to or unwilling to take a pregnancy test or to use contraception for women of child-bearing age and who are sexually active; and
•10.females minors of 12 to less than 18 years old.

发起方

Indian Council of Medical Research, (ICMR) Ministry of Health & Family welfare.