Efficacy and Bio-availability of Artemether-Lumefantrine in Severely Malnourished Children

Summary

The general objective of the study is to answer to the question: "Is the current dose of AL less efficacious in the severely malnourished compared to the non-severely malnourished children, and is PK in cause?" We aim to assess whether the current treatment dose is adequate for children with severe acute malnutrition, and we hope results will guide further recommendations for malaria treatment in this specific population.

Timeline

Start

2013-11

Primary completion

2015-03

Completion

2015-05

Publications

• Chotsiri P, Denoeud-Ndam L, Baudin E, Guindo O, Diawara H, Attaher O, Smit M, Guerin PJ, Doumbo OK, Wiesner L, Barnes KI, Hoglund RM, Dicko A, Etard JF, Tarning J. Severe Acute Malnutrition Results in Lower Lumefantrine Exposure in Children Treated With Artemether-Lumefantrine for Uncomplicated Malaria. Clin Pharmacol Ther. 2019 Dec;106(6):1299-1309. doi: 10.1002/cpt.1531. Epub 2019 Jul 23.
• Denoeud-Ndam L, Dicko A, Baudin E, Guindo O, Grandesso F, Diawara H, Sissoko S, Sanogo K, Traore S, Keita S, Barry A, de Smet M, Lasry E, Smit M, Wiesner L, Barnes KI, Djimde AA, Guerin PJ, Grais RF, Doumbo OK, Etard JF. Efficacy of artemether-lumefantrine in relation to drug exposure in children with and without severe acute malnutrition: an open comparative intervention study in Mali and Niger. BMC Med. 2016 Oct 24;14(1):167. doi: 10.1186/s12916-016-0716-1.
• 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. 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. BMC Infect Dis. 2015 Jun 12;15:228. doi: 10.1186/s12879-015-0963-3.

Drugs

Indications