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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
113
Dose based on body weight
Sanofi-Aventis Administrative Office
Porto-Novo, Benin
Sanofi-Aventis Administrative Office
Ouagadougou, Burkina Faso
Sanofi-Aventis Administrative Office
Libreville, Gabon
Sanofi-Aventis Administrative Office
Dodoma, Tanzania
Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h
Time frame: 3 initial days
Parasite reduction
Time frame: 3 initial days (72h)
Safety assessment
Time frame: 28 days post 1st study drug administration
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