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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

机译:一项多中心开放标签的试验比较蒿甲醚-卢美他汀在患有严重急性营养不良的儿童与没有严重急性营养不良的儿童中的功效和药代动力学:MAL-NUT研究的研究方案

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摘要

BackgroundMalnutrition 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.
机译:背景营养不良和疟疾在撒哈拉以南非洲国家经常并存。抗疟疾治疗功效的研究通常遵循WHO规范的协议,其中有系统地排除严重营养不良的儿童。很少有研究评估氯喹,磺胺多辛-乙胺嘧啶和奎宁对严重急性营养不良儿童的功效。总体而言,这些治疗方法的功效似乎有所降低,这归因于免疫力降低以及某些抗疟药改变了药代动力学特性并降低了药物浓度。然而,目前尚缺乏关于青蒿素联合疗法(ACTs)尤其是蒿甲醚-萤石黄嘌呤对营养不良儿童的功效和药代动力学研究的研究。与非SAM儿童相比,严重急性营养不良(SAM)严重,如果如此,这在多大程度上可归因于药代动力学欠佳。

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