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

基本信息

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
项目类别：
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

项目摘要

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贫血（SCA）的儿童患疟疾的风险很高。非洲的其他高风险群体（包括孕妇和婴儿）也被管理间歇性预防疗法与抗疟疾药物减少疟疾的燃烧，但要做的策略因此，在SCA中缺乏儿童。目前，很少有策略经过测试，没有大量样本量以疟疾和SCA的临床最重要结局为动力。在这个项目中，我们提案一项三臂，随机的，活跃的疟疾临床试验在肯尼亚西部有SCA的儿童中。利用杜克临床的临床试验专业知识研究所，杜克全球卫生研究所的全球现场研究足迹，现有与MOI大学和肯尼亚西部合作伙伴的合作，我们将入学SCA儿童肯尼亚霍马湾，这是恶性疟疾的内在。孩子将被随机分配给每日前卫（当前的护理标准），每月磺胺毒素/嘧啶 - 氨基胺或每月二氢甲酸氨酸甲胺，然后进行12个月。主要结果将是恶性疟疾的发病率和其他分配臂之间的预先指定的结果将是SCA发病率的度量疟疾严重程度，住院和死亡的措施。在研究结束时，我们期望提供使用两种替代策略来保护儿童的证据基础来自疟疾的SCA，并有可能降低非洲疟疾 - 内向区域的SCA发病率。这些数据将直接使非洲的临床医生能够改善SCA儿童的护理。