Efficacy and Safety of Artesunate-amodiaquine-methylene for Malaria Treatment in Children
Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
Participant gender:
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).
Phase:
Phase 2
Details
Lead Sponsor:
Heidelberg University
Treatments:
Amodiaquine Artemisinins Artesunate Methylene Blue