Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

Malaria Clinical Trial

Official title: An Open-label, Randomized Multicenter Study to Investigate the Anti-parasitic Activity, Pharmacokinetic and Safety of IM SAR97276A With Oral ACTs as Positive Control in Children Presenting With Symptomatic Plasmodium Falciparum Uncomplicated Malaria

Status Terminated

Clinical Trial 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

Clinical Trial Description

The total duration per patients will last approximately 28 ± 2 days broken down as follows:

• A screening phase up to 12-hours

• A 28 ± 2 days study period ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT01445938
• Study type: Interventional
• Source: Sanofi
• Status: Terminated
• Phase: Phase 2
• Start date: October 2011
• Completion date: January 2012