Extrait

Primary objective: to demonstrate the non-inferiority of PCR adjusted adequate clinical and parasitological response at D28 of artesunate + amiodaquine versus artemether + lumefantrine, based on the first malaria attack of each subject. Secondary objectives: For the first attack: To compare the two groups of treatment in terms of: - D14 efficacy - Parasitological and fever clearance - Clinical and biological tolerability - Evolution of gametocyte carriage - Cardiac tolerability (QTc) For the repeated attacks: To compare the two groups of treatment in terms of: - D14 and D28 clinical and parasitological effectiveness (PCR adjusted) - Clinical and biological tolerability - Proportion of patients without fever at D3 - Proportion of patients without parasite at D3 - Compliance - Impact on anaemia During the total follow-up of the cohort: To compare the two groups of treatment in term of: - Treatment incidence density - Impact of repeated treatment on clinical and biological safety - Impact of repeated treatment on hearing capacity

Critère d'inclusion

• Malaria

Liens

• nct
• ictrp