A multicenter, randomized controlled trial of single and multiple dose regimes of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis

奥芬达唑单剂量和多剂量方案治疗轻度（一处或两处病变）脑实质囊尾蚴病的多中心、随机对照试验

• 批准号: 10704359
• 负责人: Hector Hugo Garcia
• 金额: $ 51.47万
• 依托单位: UNIVERSIDAD PERUANA CAYETANO HEREDIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10704359
• 关键词: Aftercare; Albendazole; Antiparasitic Agents; Brain; Central Nervous System; Childhood; Cicatrix; Clinical; Clinical effectiveness; Cognitive deficits; Cohort Studies; Combined Modality Therapy; Cyst; DNA; Data; Developed Countries; Development; Diagnosis; Disease; Dose; Double-Blind Method; Early identification; Epilepsy; Evaluation; Future; Geographic Locations; Gliosis; Goals; Human; Image; Immigrant; India; Individual; Infection; Larva; Lesion; Leukocytes; Magnetic Resonance Imaging; Morbidity - disease rate; Names; Neurocysticercosis; Neurologic; Oral; Parasites; Peru; Population; Praziquantel; Principal Investigator; Prognosis; Publications; Quality of life; Radiology Specialty; Randomized, Controlled Trials; Regimen; Residual state; Resolution; Safety; Sampling; Seizures; Serum; Taenia solium; Testing; Urine; Ventricular; arm; calcification; cohort; comparative efficacy; diagnostic assay; efficacy evaluation; hippocampal atrophy; imaging biomarker; improved; long-term sequelae; magnetic resonance imaging biomarker; programs; response; safety assessment; tool; treatment choice

Oxfendazole in Neurocysticercosis Principal Investigator/Program Director: GARCIA, Hector H. A multicenter, randomized controlled trial of single and three-dose regimens of oxfendazole for mild (one or two lesions) parenchymal brain cysticercosis SUMMARY Taenia solium neurocysticercosis (NCC), the infection of the human central nervous system by the cystic larvae of Taenia solium, continues to be a major contributor to neurologic morbidity (particularly seizures and epilepsy) in most of the developing world, and a common diagnosis in immigrant populations in the USA and other industrialized countries. Anti-parasitic treatment destroys the brain cysts and improves the prognosis of the seizure disorder. The combination of albendazole (ABZ) plus praziquantel (PZQ) is more efficacious than ABZ alone in cases with multiple viable brain cysts, and recent publications also suggest increased efficacy in individuals with mild infections (one to two lesions, by far the most form of presentation in the Indian subcontinent, as well as in pediatric populations worldwide, in travelers to endemic regions, and in non-endemic regions such as the US). Still the efficacy of the best available regimens offer less than 70% efficacy in parenchymal brain NCC with one to two lesions. The recent development of oxfendazole (OXF) as a potential anti-parasitic agent for human use may provide a new, practical tool with increased efficacy and easier administration. We will perform a three-arm double blind, randomized controlled trial in six centers in two different geographic regions, three in India and three in Peru, to evaluate whether a single dose regime of OXF results in comparable efficacy to the currently used 10 day regime of ABZ plus PZQ, and also whether a 3-dose course of OXF can offer increased parasiticidal efficacy. The study cohort will also allow identification of early imaging markers that may predict lesion resolution in response to anti-parasitic treatment, and will provide additional data on the safety of oral OXF and factors associated to residual scarring, seizure relapses, or reduced quality of life in this population. Finally, systematic sampling in the cohort will provide defined batteries of DNA, white blood cells, serum and urine samples for future evaluation of diagnostic assays for single-lesion parenchymal NCC.

奥芬达唑治疗神经囊尾蚴病 首席研究员/项目总监：GARCIA, Hector H. 单剂量和三剂量的多中心、随机对照试验 奥芬达唑治疗轻度（一处或两处病变）的方案 脑实质囊虫病 概括 猪带绦虫神经囊尾蚴病 (NCC)，是一种由囊虫引起的人类中枢神经系统感染 猪带绦虫的幼虫仍然是神经系统疾病（特别是癫痫发作）的主要原因 和癫痫）在大多数发展中国家，这是移民人口的常见诊断 美国和其他工业化国家。抗寄生虫治疗可破坏脑囊肿并改善 癫痫病的预后。阿苯达唑（ABZ）加吡喹酮（PZQ）的组合更有效 对于患有多个存活脑囊肿的病例，比单独使用 ABZ 更有效，最近的出版物也表明 提高轻度感染个体的疗效（一到两个病变，迄今为止最常见的感染形式） 在印度次大陆以及世界各地的儿科人群中、在前往印度次大陆的旅行者中进行的介绍 流行地区和非流行地区（例如美国）。仍然具有现有最佳功效 对于具有 1 至 2 个病变的脑实质 NCC，治疗方案的疗效低于 70%。最近的 奥芬达唑（OXF）作为一种潜在的人类抗寄生虫药的开发可能提供一种新的、 实用的工具，具有更高的功效和更容易的管理。我们将进行三臂双盲， 在两个不同地理区域的六个中心进行的随机对照试验，其中三个在印度，三个在印度 秘鲁，评估 OXF 的单剂量方案是否具有与目前使用的药物相当的功效 ABZ 加 PZQ 的 10 天治疗方案，以及 OXF 的 3 剂疗程是否可以增强杀寄生虫作用 功效。该研究队列还将识别可预测病变的早期成像标记物 针对抗寄生虫治疗的决议，并将提供有关口服 OXF 安全性的额外数据 以及与该人群中残留疤痕、癫痫复发或生活质量下降相关的因素。 最后，队列中的系统采样将提供确定的 DNA、白细胞、血清组 和尿液样本，用于未来评估单病灶实质 NCC 的诊断分析。