Focal mass drug administration (fMDA) to reduce Plasmodium vivax transmission, a pragmatic cluster randomized controlled trial in Peru

旨在减少间日疟原虫传播的集中集中药物管理（fMDA），这是秘鲁的一项实用整群随机对照试验

• 批准号: 10488139
• 负责人: Michelle Sang Hsiang
• 金额: $ 129.35万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-10 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10488139
• 关键词: Address; Adherence; Aftercare; Aminoquinolines; Antimalarials; Applied Research; Blood; Case Management; Chloroquine; Clinical; Communicable Diseases; Communities; Consent; Cost Measures; Country; Data; Detection; Diagnostic; Dose; Drug Targeting; Drug resistance; Effectiveness; Eligibility Determination; Family; Genetic Variation; Glucosephosphate Dehydrogenase; Glucosephosphate Dehydrogenase Deficiency; Half-Life; Health system; Hemolysis; Household; Incidence; Individual; Infection; Intervention; Lead; Life; Liver; Malaria; Mass Screening; Measures; Microscopy; Mission; National Institute of Allergy and Infectious Disease; Outcome; Peru; Pharmaceutical Preparations; Plasmodium falciparum; Plasmodium vivax; Policies; Population; Prevalence; Primaquine; Public Health; Randomized; Randomized Controlled Trials; Recommendation; Relapse; Safety; Seasons; Serious Adverse Event; Seroprevalences; Testing; Vivax Malaria; adverse event risk; arm; asexual; base; burden of illness; comparative efficacy; cost; cost effective; cost effectiveness; cost-effectiveness ratio; density; effectiveness evaluation; follow-up; high risk; improved; incremental cost-effectiveness; indexing; infection risk; member; meter; novel therapeutics; open label; pharmacovigilance; point of care; point of care testing; prevent; primary outcome; prophylactic; public health relevance; rapid test; risk minimization; secondary endpoint; secondary outcome; standard of care; tool; transmission process; treatment arm; treatment effect; urban area; vector control

Project Summary/Abstract In most countries approaching elimination, Plasmodium vivax (Pv) represents an increasing proportion relative to P. falciparum (Pf). Mass drug administration (MDA), as a way target subpatent, asymptomatic infections, is recommended for P. falciparum elimination, but the recommendation does not extend to P. vivax given limited evidence, tools, and safety concerns. The objective of our study is to evaluate the long-term impact, safety, and cost-effectiveness of focal MDA (fMDA) for Pv transmission reduction. To test our hypothesis that fMDA, in addition to standard aggressive interventions, will safely reduce transmission, we propose a 3-year open-label CRCT in the low endemic setting of Loreto Region, Peru. Villages or clusters will be randomized to control or fMDA. The control arm will receive standard interventions (vector control, symptomatic case management, and active case detection of asymptomatic cases). The treatment arm will receive standard interventions plus fMDA, which will utilize a new drug for radical cure of P. vivax, tafenoquine, and a new quantitative glucose 6 phosphate dehydrogenase (G6PD) deficiency rapid test to support safe administration of tafenoquine. fMDA will be targeted to consenting and eligible high-risk villagers, defined as household members and neighbors of recent Pv index cases. fMDA will be conducted in 2 rounds per year, two months apart during the low malaria season, and over 3 years. Eligibility will be re-assessed each year, and prior to each fMDA round. Specific aims are to: 1) Determine the effectiveness of fMDA to reduce Pv transmission as measured in a primary outcome of incidence and secondary outcomes of infection prevalence, seroprevalence, and genetic diversity, 2) Evaluate the safety and tolerability of fMDA, and 3) Measure the cost-effectiveness of fMDA. To maximize

项目摘要/摘要 在大多数国家接近消除的国家中，疟原虫（PV）代表了相对比例的越来越多 到恶性疟原虫（PF）。大众药物给药（MDA）作为目标亚pit靶的方式，无症状感染，是 建议用于消除恶性疟原虫，但建议不扩展到Vivax有限 证据，工具和安全问题。我们研究的目的是评估长期影响，安全性， 局灶性MDA（FMDA）用于降低光伏传输的成本效益。为了检验我们的假设，即FMDA， 除了标准的积极干预措施外，还将安全减少传输，我们提出了3年的开放标签 秘鲁洛雷托地区低流行环境中的CRCT。村庄或集群将被随机进行控制或 FMDA。控制部门将接受标准干预措施（向量控制，有症状的病例管理和 无症状病例的主动病例检测）。治疗部门将接受标准干预措施加上FMDA， 它将利用一种新药物来固化Vivax，tafenoquine和一种新的定量葡萄糖6 磷酸盐脱氢酶（G6PD）缺乏快速测试，以支持tafenoquine的安全给药。 FMDA 将针对同意和合格的高风险村民，定义为家庭成员和邻居 最近的PV指数案例。 FMDA将每年2轮进行，在低疟疾期间相隔两个月 季节，超过3年。每年和每次FMDA回合之前，资格将被重新评估。具体的 目的是：1）确定FMDA降低PV传输的有效性 感染患病率，血清阳性和遗传多样性的发生率和继发结果的结果， 2）评估FMDA的安全性和耐受性，3）测量FMDA的成本效益。最大化