Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient. Secondary objectives: For the first attack: To compare the 2 groups of treatment in terms of: * Day 42 efficacy * Parasitological and fever clearance * Clinical and Biological tolerability * Evolution of gametocyte carriage For attack 2nd and following: To compare the 2 groups of treatment in terms of: * Day 28 and Day 42 clinical and parasitological effectiveness * Clinical and Biological tolerability * Proportion of patients without fever at Day 3 * Proportion of patients without parasites at Day 3 * Evolution of gametocyte carriage * Compliance During the total follow up of the cohort: To compare the 2 groups of treatment in terms of: * Treatment incidence density * Impact of repeated treatment on clinical and biological tolerability * Impact on anaemia * Impact on Hackett score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
413
Oral route, once daily, dose according to bodyweight range Duration of treatment: 3 days
Oral route, twice daily, dose according to bodyweight range Duration of treatment: 3 days
Sanofi-aventis administrative office
Kampala, Uganda
PCR corrected and uncorrected clinical and parasitological cure rate
Time frame: At Day 28
Fever and parasitological clearance evaluation by measuring the axillary temperature and monitoring paratesimia
Time frame: At the first attack
Proportion of afebrile patients and proportion of patients without parasites
Time frame: At Day 3 (following attacks)
Evolution of baseline symptoms (Clinical efficacy measure)
Time frame: During the study conduct
Number of residual tablets in blisters (compliance)
Time frame: At the end of the study treatment
Treatment incidence density: comparison of the number of malaria attacks between the 2 arms
Time frame: During the 2 years of follow-up
Mean delay between 2 attacks
Time frame: during the 2 years of follow-up
Incidence and intensity of recorded AE
Time frame: from the informed consent signed up to the end of the study
Biological tolerability (Hb, Bilirubin, ALAT, Creatinine, Leucocytes, Neutrophils and Platelets count)
Time frame: During the study conduct
PCR corrected and uncorrected clinical and parasitological cure rate
Time frame: At Day 42
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