Primary Objective: \- To demonstrate the non-inferiority of corrected adequate clinical and parasitological response at Day 28 of Artesunate Amodiaquine (ASAQ) versus chloroquine Secondary Objectives: * To assess the non inferiority on the same way as the main criteria: * at Day 28 before corrected cure rate * at Day 14 and Day 42 before and after corrected cure rate * To compare the two groups of treatment in terms of: * Efficacy: * Proportion of aparasitaemic patients at 24, 48 an 72 hours * Proportion of afebrile patients at 24, 48 and 72 hours * Percentage of gametocyte carriers during follow-up * Evolution of the mean of gametocytes during the 42 days of follow-up * Evolution of haemoglobin value between Day 0 and Day 7, Day 0 and Day 28 * Clinical and biological tolerability: * Proportion of any adverse event * Biological safety: haematology (Red blood cells, Haemoglobin, White Blood Cells, neutrophils, platelets), biochemistry (creatinine, transaminases (alanine amino transferase/ALT), bilirubins) * ECG (electro encephalogram) (Day 0, Day 3,Day 28) only for patients 10 years old and above
Each patient will be followed for a period of 42 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
380
Pharmaceutical form: Route of administration:
Pharmaceutical form:tablet Route of administration: oral
Administrative office
São Paulo, Brazil
Assessment of clinical and parasitological efficacy based on temperature and parasitemia after Polymerase chain reaction (PCR) correction
Time frame: 28 days
Assessment of clinical and parasitological efficacy based on temperature and parasitemia before and after PCR correction at D14 and D42 and before PCR correction at D28
Time frame: up to a maximum of 42 days
Number of patients without parasite
Time frame: up to a maximum of 42 days
Number of patients without fever
Time frame: up to a maximum of 42 days
Number of patients with gametocytes
Time frame: up to a maximum of 42 days
Change from baseline in Haemoglobin levels
Time frame: Day 7, Day 28
Incidence and severity of adverse events collected
Time frame: up to a maximum of 42 days
ECG (QTc) changes in patients group aged >= 10 years from baseline
Time frame: Day 3, Day 28
Assessment of biological tolerability (bilirubin, ALAT, Creatinine, Leukocytes, Neutrophils and platelets count) from baseline
Time frame: up to a maximum of 42 days
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