Uncomplicated Falciparum Malaria Clinical Trial
Official title:
Efficacy and Safety of Artesunate-amodiaquine Combined With Methylene Blue for Falciparum Malaria Treatment in African Children
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).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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