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