Malaria Clinical Trial
Official title:
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. ;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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