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

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

Timeline

Start

2011-10

Primary completion

2012-01

Completion

2012-01

Publications

• Held J, Supan C, Salazar CLO, Tinto H, Bonkian LN, Nahum A, Sie A, Abdulla S, Cantalloube C, Djeriou E, Bouyou-Akotet M, Ogutu B, Mordmuller B, Kreidenweiss A, Siribie M, Sirima SB, Kremsner PG. Safety and efficacy of the choline analogue SAR97276 for malaria treatment: results of two phase 2, open-label, multicenter trials in African patients. Malar J. 2017 May 4;16(1):188. doi: 10.1186/s12936-017-1832-x.

Drugs

Indications