Safety and Efficacy Study of Artesunate and Mefloquin in Children With Uncomplicated Malaria

Inclusion Criteria: * Body weight from ≥ 10 kg to ≤ 20 kg. * Presence of acute uncomplicated P. falciparum malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum only. * Counts of asexual forms of P. falciparum: 2'000 to 250'000 parasites per µL of blood. * Presence of fever defined as axillary temperature of ≥37.5 °C (≥ 38 °C if oral, rectal or tympanic temperature) or a history of fever within the last 24 hours. * Written informed consent provided by the patient and parent or guardian. If the person is unable to write, thumb print witnessed consent is permitted. * Willingness and ability of the patient and the parent or guardian to comply with study protocol for the duration of the study. * Patients who are able to take oral medication. Exclusion Criteria: * Patients with severe/complicated malaria as defined by the World Health Organization, 2000, Severe falciparum malaria (18). * Known history or evidence of clinically significant disorders: neurological, psychiatric (depression, psychosis or schizophrenia), cardiovascular (including arrhythmia), pulmonary, metabolic, gastrointestinal, endocrine diseases or malignancies. * Patients with a history of epilepsy or of convulsions. * Patients who received any anti-malarial treatment within 7 days prior to enrolment including any substance with anti-malarial activity, e.g. antibiotics)or treatment with mefloquine within 30 days prior to enrolment. * Patients with a hypersensitivity or allergic reaction to artemisinins or mefloquine or any chemically related entity (e.g. quinine). * Patients who participated in any investigational drug trial within 30 days prior to enrolment. * Patients with vomiting 3 or more times within 24 hours of enrolment or more than 3 copious liquid stools within 24 hours. * Patients with known renal impairment. * Patients who do require parenteral treatment. * Patients who have had a splenectomy. * Known immunocompromised patients and who are receiving immunosuppressive agents and/or patients with known human immunodeficiency virus (HIV) infection.