Safety Pharmacokinetics & Efficacy of Artemether & Lumefantrine in Pregnant Women

安全药代动力学

• 批准号: 7360186
• 负责人: MARK H MIROCHNICK
• 金额: $ 12.32万
• 依托单位: BOSTON MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-07-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7360186
• 关键词: Antimalarials; Biological Assay; Blood; Blood specimen; Clinical Trials; Collaborations; Data; Data Collection; Dose; Drug Combinations; Drug Formulations; Drug Kinetics; Drug toxicity; Drug usage; Enrollment; Ensure; Fansidar; Fever; Grant; Infant; Laboratories; Malaria; Monitor; Mothers; Parasites; Patient currently pregnant; Patients; Pharmaceutical Preparations; Pharmacology; Phase; Population; Pregnant Women; Protein Binding; Protocols documentation; Public Health; Pyrimethamine-Sulfadoxine; Research Personnel; Safety; Study Subject; Symptoms; Woman; Zambia; artemether; benflumetol; design; human study; prevent; tool

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.

描述（由申请人提供）：迫切需要更多数据来描述用于治疗和预防孕妇疟疾的药物的药理学。本申请的目的是制定一项方案，研究两种常用于治疗和预防疟疾的组合药物产品——复方蒿甲醚（蒿甲醚-苯芴醇）和 Fansidar（磺胺多辛-乙胺嘧啶）对赞比亚孕妇的安全性、有效性和药代动力学。该协议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患有单纯性疟疾的赞比亚孕妇。参加试验的女性将接受两种研究药物配方中的一种，然后进行连续血液采样以检测抗疟疾药物浓度和蛋白质结合。将监测研究对象的疟疾症状和血液疟原虫载量的变化。研究母亲及其婴儿还将受到药物毒性迹象的监测。这笔规划拨款将用于制定该临床试验所需的详细方案，开发受试者招募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测定。这项计划研究的数据将提供确保孕妇接受适当剂量的这些抗疟疾药物所需的信息。