Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
Status:
Terminated
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
Primary Objective:
To assess the antiparasitic activity of intramuscular (IM) SAR97276A based on parasite
reduction ratio at 72 hours in pediatric patients with uncomplicated malaria
Secondary Objectives:
- To assess the evolution of clinical signs and symptoms (including the need for a rescue
therapy) in pediatric patients with uncomplicated malaria receiving SAR97276A with
reference to Artemisinin-Based Combination Therapy (ACTs)
- To assess the pharmacokinetics profile of SAR97276A in pediatric patients with
uncomplicated malaria
- To assess the safety profile of SAR97276A in pediatric patients with uncomplicated
malaria
- To assess the pharmacokinetic-pharmacodynamic relationship of SAR97276A