Safety Pharmacokinetics & Efficacy of Artemether & Lumefantrine in Pregnant Women

描述(由申请人提供)：迫切需要更多的数据来描述用于治疗和预防孕妇疟疾的药物的药理学。这项申请的目的是规划一项方案，研究常用的两种治疗和预防疟疾的联合药物产品--复方蒿甲醚(蒿甲醚-鲁米芬)和芬西达(磺胺多辛-乙胺嘧啶)--在赞比亚孕妇中的安全性、有效性和药代动力学。该议定书将与赞比亚调查人员和公共卫生官员合作制定。该方案的患者群体将是赞比亚患有简单疟疾的孕妇。参加试验的女性将接受两种研究药物配方中的一种，随后将连续抽血检测抗疟疾药物浓度和蛋白质结合情况。研究对象将被监测疟疾症状和血液疟疾寄生虫载量的变化。研究母亲和她们的婴儿也将接受监测，看是否有任何药物毒性的迹象。这笔规划拨款将用于制定这项临床试验所需的详细方案，开发受试者登记和数据收集所需的所有工具，获得适当的人体研究批准，并开发必要的实验室分析。这项计划研究的数据将提供必要的信息，以确保孕妇获得适当剂量的这些抗疟疾药物。

DESCRIPTION (provided by applicant): More data are urgently needed describing the pharmacology of drugs used to treat and prevent malaria in pregnant women. The aim of this application is to plan a protocol that will study the safety, efficacy and pharmacokinetics in Zambian pregnant women of 2 combination drug products commonly used to treat and prevent malaria - Coartem (artemether-lumefantrine) and Fansidar (sulfadoxine-pyrimethamine). This protocol will be developed in collaboration with Zambian investigators and public health officials. The patient population for the protocol will be pregnant women in Zambia who have uncomplicated malaria. Women enrolling in the trial will receive one of the two study drug formulations, followed by serial blood sampling for anti-malaria drug concentrations and protein binding. Study subjects will be monitored for change in malaria symptoms and the blood malaria parasite load. Study mothers and their infants will also be monitored for any signs of toxicity from the drugs. This planning grant will be used to develop the detailed protocol needed for this clinical trial, to develop all the tools needed for subject enrollment and data collection, to obtain appropriate human studies approvals and to develop the necessary laboratory assays. The data from this planned study will provide the information needed to ensure that pregnant women receive the appropriate doses of these anti-malaria drugs.