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v2.1.4829.produseast1

Protocol > Research Protocol

A multi-center, open-label trial to compare the efficacy and pharmacokinetics of Artemether-Lumefantrine in children with severe acute malnutrition versus children without severe acute malnutrition: study protocol for the MAL-NUT study

Denoeud-Ndam L, Dicko A, Baudin E, Guindo O, Grandesso F, Sagara I, Lasry E, Palma PP, Parra AM, Stepniewska K, Djimde AA, Barnes KI, Doumbo OK, Etard JF
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Abstract
Malnutrition and malaria frequently coexist in sub-Saharan African countries. Studies on efficacy of antimalarial treatments usually follow the WHO standardized protocol in which severely malnourished children are systematically excluded. Few studies have assessed the efficacy of chloroquine, sulfadoxine-pyrimethamine and quinine in severe acute malnourished children. Overall, efficacy of these treatments appeared to be reduced, attributed to lower immunity and for some antimalarials altered pharmacokinetic profiles and lower drug concentrations. However, similar research on the efficacy and pharmacokinetic profiles of artemisinin-combination therapies (ACTs) and especially artemether-lumefantrine in malnourished children is currently lacking. The main objective of this study is to assess whether artemether-lumefantrine is less efficacious in children suffering from severe acute malnutrition (SAM) compared to non-SAM children, and if so, to what extent this can be attributed to a sub-optimal pharmacokinetic profile.
Countries
MaliNiger
Subject Area
malariamalnutrition
DOI
10.1186/s12879-015-0963-3
Published Date
12-Jun-2015
PubMed ID
26068100
Languages
English
Journal
BMC Infectious Diseases
Volume / Issue / Pages
Volume 15, Issue 1
Issue Date
12-Jun-2015
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