Artesunate Plus Amodiaquine in Malaria in Cote d'Ivoire

A Nested Open Labeled Study to Compare the Effectiveness and Safety of a Fixed-dose Combination of Artesunate Plus Amodiaquine (ASAQ Winthrop®) in the Unsupervised Treatment of Uncomplicated Plasmodium Falciparum Malaria Attacks in Two Patient Groups Enrolled at Two Year-intervals in a Pilot District of Côte d'Ivoire

The primary objective of this study is to demonstrate the non-inferiority of Polymerase Chain Reaction (PCR)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at Day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later.

The secondary objectives are Clinical and biological tolerability Evolution of gametocyte carriage Proportion of patients without fever at Day 3 Proportion of patients without parasite at Day 3 Treatment compliance Impact of implementation on anemia Measure of parasite sensibility to amodiaquine

Inclusion Criteria:

• Body weight >=5kg
• Plasmodium falciparum infection with parasite density > 2000/µL
• Fever or history of fever
• Able to be treated by oral route
• No signs of severe malaria
• No known allergy to study drugs
• No other severe illnesses or underlying diseases
• No known pregnancy or negative urinary pregnancy test for women of child bearing age
• No participation in another ongoing clinical study

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