Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
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
Lists of Inclusion and Exclusion criteria:

 Inclusion Criteria:

 -  adults or children weighting more than 5 kg

 -  axillary temperature >=37.5°C at D0 or history of fever within the previous 24hrs

 -  confirmed Plasmodium falciparum monoinfection, with parasitemia>1000mcl

 -  negative urinary pregnancy test for women of child bearing age before each new
 administration of treatment

 Exclusion Criteria:

 -  presence of any serious or clinical danger sign of malaria: prostration, consciousness
 disorders, recent and repeated convulsions, respiratory distress, inability to drink,
 uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock,
 systolic BP< 70 mmHg in adults or < 50 mmHg in children, spontaneous bleeding,
 inability to sit or stand

 -  severe concomitant disease

 -  allergy to one of the investigational drugs.

 The above information is not intended to contain all considerations relevant to a patient's
 potential participation in a clinical trial.