Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.

A Multicenter, Open Label, Efficacy and Safety Study of Parenteral SAR97276A in the Treatment of Symptomatic Uncomplicated and Severe Malaria in Adults and Children

The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria.

The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.

The treatment will be administered by intramuscular or intravenous route depending on the cohort. The treatment will be administered as single dose or 3-day repeated dose. The patients will be hospitalized for 3 days and followed up to 28 days following study treatment.

Inclusion Criteria:

• Adult patients with uncomplicated malaria will be enrolled in cohort 1
• Pediatric patients with uncomplicated malaria will be enrolled in cohort 2
• Pediatric patients with severe malaria will be enrolled in cohort 3
• Plasmodium falciparum malaria confirmed in blood smear
• Fever within the last 24 hours.

Exclusion Criteria:

• Treatment with an antimalarial agent within 72h of screening
• Severe concomitant disease
• Pregnant or breast-feeding women
• Women of child bearing potential not protected by an effective method of birth control

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