Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children

Summary

Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial. Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Phase: Phase II. Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen. Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso. Sample size: 180 patients (90 per study arm).

Timeline

Start

2011-08

Primary completion

2011-08

Completion

2011-12

Publications

• Coulibaly B, Pritsch M, Bountogo M, Meissner PE, Nebie E, Klose C, Kieser M, Berens-Riha N, Wieser A, Sirima SB, Breitkreutz J, Schirmer RH, Sie A, Mockenhaupt FP, Drakeley C, Bousema T, Muller O. Efficacy and safety of triple combination therapy with artesunate-amodiaquine-methylene blue for falciparum malaria in children: a randomized controlled trial in Burkina Faso. J Infect Dis. 2015 Mar 1;211(5):689-97. doi: 10.1093/infdis/jiu540. Epub 2014 Sep 28.

Drugs

Indications