drugset / Trial / NCT01204411

Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010

NCT01204411

NaSingle-groupOpen-labelTreatment

Summary

The purpose of the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition. Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and mortality in malnourished children. Malnutrition is known to have a modulating effect on the incidence of malaria infections, its severity and effectiveness of treatments. However, little data exists on antimalarial drug efficacy in malnourished children. Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine is based on non malnourished children. The aim of this study is to measure the clinical and parasitological efficacy in severely malnourished children. The study is consistent with the standard WHO protocol for monitoring antimalarial drug efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of being an exclusion criteria. The study will encompass a pharmacokinetic part that will provide important information on the absorption of the drug.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Artesunate Small molecule 25 mg
Subject Artesunate Small molecule 50 mg
Subject Artesunate Small molecule 100 mg
Subject amodiaquine Other / unclassified 67.5 mg
Subject amodiaquine Other / unclassified 135 mg
Subject amodiaquine Other / unclassified 270 mg