Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets in African Infants and Children With Uncomplicated P. Falciparum Malaria

Open Label, Multicenter Study for Evaluation of Safety and Efficacy of Artemether-Lumefantrine Tablets (6-Dose Regimen) in African Infants and Children in the Treatment of Acute Uncomplicated Falciparum Malaria

This study will assess the safety and efficacy of artemether-lumefantrine tablets (6-dose regimen) in African infants / children with acute uncomplicated falciparum malaria.

Inclusion Criteria:

• male or female weighing ≥ 5kg and ≤ 25kg
• P. falciparum parasitemia between 1,000 and 100,000 parasites/mm3
• with confirmed diagnosis of uncomplicated malaria caused P. falciparum parasite

Exclusion Criteria:

• complicated malaria
• ingestion of various antimalarial drugs, or other drugs influencing cardiac function in the previous 4 weeks before study entry to 8 weeks
• severe anaemia
• severe malnutrition
• malaria due to other than P. falciparum

Other protocol-defined inclusion/exclusion criteria may apply