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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
366
Infants tablets: AS 25/AQ 67,5 mg Toddlers tablets: AS 50/AQ 135 mg Once daily, dose according to bodyweight range Duration of treatment: 3days Children tablets: AS 100/AQ 270 mg
Tablets, 20/120 mg, oral route, twice daily, dose according to bodyweight range. Duration of treatment: 3 days
Sanofi-Aventis Administrative Office
Dakar, Senegal
PCR corrected and uncorrected clinical and parasitological cure rate
Time frame: at D28 and for the first attack
PCR corrected and uncorrected clinical and parasitological cure rate
Time frame: at D28 and for the next attacks
Fever and parasitological clearance
Time frame: first attack
Proportion of afebrile patients and proportion of patients without parasites
Time frame: at D3 for the following attacks
Clinical tolerability (incidence and intensity of recorded AE)
Time frame: during the study period
Biological tolerability (Hb, bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count)
Time frame: during the study period
Cardiac tolerability (QTc) for the first attack in patients group aged >= 12 years)
Time frame: at the time of the first attack
Assessment and evolution of hearing function in patients groupe aged >=12 years
Time frame: during the study period
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