Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks

Inclusion criteria

Specific inclusion criteria for initial enrollment:

• Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood,

Inclusion criteria

for each attacks:

• Body weight ≥5 kg
• Able to be treated by oral route
• Fever (axillary temperatur ≥37.5 degrees Celsius) at D0 or history of fever within the previous 24 hours
• Confirmed Plasmodium falciparum infection with positive paratesimia
• Haemoglobin value ≥5.0 g/dl

Exclusion criteria

Specific exclusion criteria for initial enrollment:

• Patient participating in another ongoing clinical trial
• Allergy to one of the investigational medicinal products
• History of hepatic and (or) haematological impairment during treatment with amodiaquine
• History of cardiac disease
• Concomitant febrile illness

Exclusion criteria

for each attacks:

• Presence of at least one danger sign of malaria: recent history of convulsions (1-2 within 24h), unconsciousness state, lethargy, unable to drink or breast feed, vomiting everything, unable to stand/sit due to weakness
• Severe concomitant disease or known disturbances of electrolyte balance such as hypokalaemia or hypomagnesaemia
• Intake of medication metabolized by cytochrome CYP 2D6 (e.g. metoprolol, flecainide, imipramine, amitriptyline, clomipramine) at the time of inclusion
• Intake of drugs known to inhibit CYP 2A6 (e.g. methoxsalem, pilocarpine, tranylcypromine) and/or 2C8 cytochromes (e.g. trimethoprim, ritonavir, ketoconazole, montelukast, gemfibrozil) at the time of inclusion
• Intake of medication known to prolong the QTc interval, such as class IA and III antiarrythmics, neuroleptics, antidepressant agents, certain antibiotics including drugs in the macrolide class, fluoroquinolones, imidazole and triazole, antifungal agents, certain non-sedative anthistamines (terfenadine, astemizole) and cisapride at the time of inclusion
• Patient having received artesunate + amiodaquine or artemether + lumefantrine at suitable dosage within the previous 2 weeks.

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