Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria

Inclusion Criteria: * Children aged between 6 and 59 months * Minimum body weight of 5kg * Presence of fever (Temp \>/= 37.5°C) or a history of fever in the last 24 hours * Presence of asexual P. falciparum monoinfection * Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood * Not suffering from severe and complicated forms of malaria * Able to take drugs under study by the oral route * Parent or guardian gives informed written consent to participate in study Exclusion Criteria: * Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/\<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (\>200,000 µl) * Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0 * Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria * Patients with vomiting and/or diarrhoea * Signs of severe malnutrition (defined as follows: children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet) * Presence of general danger signs in children below 5 years or other signs of serious and complex Plasmodium falciparum, as stated in the present WHO definitions * Patients with known history of heart disease or arrhythmia * History of allergy to artemether/lumefantrine or quinine