Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.

A Randomized, Investigator-Blinded, Multicenter, Parallel-Group Study to Compare Efficacy, Safety and Tolerability of Arthemeter/ Lumefantrine Dispersible Tablet Formulation vs. Artemether/ Lumefantrine 6-Dose Crushed Tablet in the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Infants and Children.

This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.

Inclusion Criteria:

• male or female infants and children ≤12 years of age
• body weight of ≥5 kg and <35 kg,
• with a confirmed diagnosis of uncomplicated malaria caused by the P. falciparum parasite

Exclusion Criteria:

• complicated malaria
• persistent vomiting
• malaria due to parasites other than P. falciparum
• antimalarial treatment received in the past 2 weeks
• known chronic disease e.g. positive HIV status, severe cardiac, renal, or hepatic disease