Efficacy, Safety and Population-Pharmacokinetics of Artesunate-Mefloquine combination for the Treatment of Uncomplicated Falciparum Malaria in African children versus Artemether-Lumefantrine

DNDi0 个研究点目标入组 940 人开始时间: 2011年2月16日最近更新: 2023年5月29日

适应症

试验速览

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•1. Age between 6 to 59 months.
•2. Presence of acute uncomplicated P. falciparum mono-infection confirmed by:
•a. Axillary temperature >37.5°C and,
•b. Positive microscopy of P. falciparum with parasite density between 2,000 and 200,000 asexual parasites/µl
•3. Written informed consent from parent/guardian

•1. Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000
•2. Weight < 5kg
•3. Inability to tolerate oral medication (presence of any of the following danger signs: unable to drink or breastfeed, severe vomiting, recent history of convulsions, lethargic or unconscious state, unable to sit or stand up)
•4. Mixed Plasmodium infection.
•5. Presence of febrile conditions caused by diseases other than malaria.
•6. Known history of hypersensitivity, allergic or serious adverse reactions to Mefloquine, Quinine, Quinidine, Artesunate or other Artemisinins.
•7. History of use of any anti-malarial agent within 2 weeks prior to start of the study (except mefloquine and piperaquine within 4 weeks).
•8. Prior participation to a therapeutic trial within 3 months.

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