Malnutrition Clinical Trial
Official title:
Efficacy of the Artesunate-amodiaquine Combination for Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Between 6 and 59 Months of Age With Severe Acute Malnutrition in Madaoua, Tahoua Region, Niger
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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