Cohort Study in Senegal Comparing Artesunate + Amiodaquine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

A Randomized Study to Compare Artesunate + Amiodaquine Versus Artemether + Lumefantrine in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks Occurring During 2 Years in a Cohort in Senegal

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.