Malaria chemoprevention in children with sickle cell anemia in Western Kenya

肯尼亚西部镰状细胞性贫血儿童的疟疾化学预防

• 批准号: 9279261
• 负责人: Steve Myer Taylor
• 金额: $ 65.37万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2021-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9279261
• 关键词: 10 year old; Africa; Africa South of the Sahara; African; Amodiaquine; Antimalarials; Area; Biological Assay; Blood Circulation; Cessation of life; Chemoprevention; Chemoprophylaxis; Child; Child Care; Child health care; Childhood; Chloroguanide; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Data; Drug resistance; Enrollment; Epidemiologist; Event; Falciparum Malaria; Fever; Generations; Goals; Hematology; Hospitalization; Incidence; Individual; Infant; Infection; Institutes; Kenya; Malaria; Malaria prevention; Measures; Morbidity - disease rate; Newborn Infant; Outcome; Pain; Parasites; Participant; Patients; Pharmaceutical Preparations; Placebos; Plasmodium falciparum; Policies; Population; Pregnant Women; Prevalence; Prevention strategy; Preventive therapy; Prophylactic treatment; Pyrimethamine-Sulfadoxine; Randomized; Regimen; Research; Research Institute; Resistance; Sample Size; Schedule; Severities; Sickle Cell Anemia; Solid; Specialist; Supportive care; Testing; Transfusion; Universities; arm; base; comparative efficacy; design; efficacy trial; evidence base; experience; global health; high risk; high risk population; improved; malaria transmission; molecular marker; multidisciplinary; open label; pressure; prevent; primary outcome; programs; standard of care

Children with sickle cell anemia (SCA) in sub-Saharan Africa are at high risk to suffer from malaria. Other high-risk groups in Africa – including pregnant women and infants – are administered intermittent preventive therapy with antimalarials to reduce the burden of malaria, but strategies to do so in SCA children are lacking. Currently, few strategies have been tested, and none with large sample sizes powered on clinically-important outcomes for malaria and SCA. In this project, we propose a three-arm, randomized, active-placebo clinical trial of malaria chemoprophylaxis regimens in children with SCA in Western Kenya. Capitalizing on the clinical trial expertise of the Duke Clinical Research Institute, the global field research footprint of the Duke Global Health Institute, and existing collaborations with Moi University and partners in Western Kenya, we will enroll children with SCA in Homa Bay, Kenya, which is endemic for falciparum malaria. Children will be randomized to either daily Proguanil (current standard of care), monthly sulfadoxine/pyrimethamine-amodiaquine, or monthly dihydroartemisinin-piperaquine, and followed for 12 months. The primary outcome will be the incidence of falciparum malaria, and other prespecified outcomes compared between allocation arms will be measures of SCA morbidity including painful events, dactylitis, and need for transfusion, measures of malaria severity, and hospitalizations and deaths. At the conclusion of the study, we expect to provide an evidence base for the use of two alternative strategies to protect children with SCA from malaria, and to potentially reduce the morbidity of SCA in malaria-endemic areas in Africa. These data will directly enable clinicians in Africa to improve the care of children with SCA.

撒哈拉以南非洲患有镰状细胞性贫血(SCA)的儿童患疟疾的风险很高。 非洲的其他高危人群--包括孕妇和婴儿--接受了 用抗疟疾药物进行间歇性预防性治疗以减轻疟疾负担，但应采取的策略 因此，在SCA中，儿童是缺乏的。目前，很少有策略被测试，也没有一种策略具有较大的 样本大小决定了疟疾和SCA的临床重要结果。在这个项目中，我们 提出一项三臂、随机、活性安慰剂的疟疾化学预防方案临床试验 在肯尼亚西部患有SCA的儿童中。利用杜克临床医院的临床试验专业知识 杜克全球卫生研究所的全球实地研究足迹，以及现有的 与肯尼亚西部的莫伊大学和合作伙伴合作，我们将招收有SCA的儿童参加 霍马湾，肯尼亚，恶性疟疾的地方病。孩子们将被随机分配到 每日普鲁瓜尼(当前护理标准)，每月磺胺多辛/乙胺嘧啶-阿莫地喹，或 每月服用双氢青蒿素-哌喹，并随访12个月。主要结果将是 分配单位之间恶性疟疾发病率和其他预先确定的结果的比较 将是衡量SCA发病率的指标，包括疼痛事件、指炎和需要输血， 衡量疟疾严重程度、住院人数和死亡人数。在研究结束时，我们 希望为使用两种替代战略保护儿童提供证据基础 防治疟疾的SCA，并有可能降低非洲疟疾流行地区的SCA发病率。 这些数据将直接使非洲的临床医生能够改善对SCA儿童的护理。