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.

神经囊虫病主要研究员/计划主管：加西亚，Hector H. 单剂量和三剂量的多中心，随机对照试验 轻度牛津唑的方案（一个或两个病变） 实质脑囊肿 概括 Taenia solium神经囊肿（NCC），囊性的人类中枢神经系统感染 taenia ilium的幼虫继续是神经系统发病率的主要因素（尤其是癫痫发作 在大多数发展中国家中的癫痫），以及移民人口的共同诊断 美国和其他工业化国家。抗寄生虫治疗会破坏脑囊肿并改善 癫痫发作的预后。 Aldendazole（ABZ）加上Praziquantel（PZQ）的组合更多 在有多个可行脑囊肿的情况下，比单独使用ABZ有效，最近的出版物也表明 在轻度感染的个体中提高功效（一到两个病变，迄今为止最多的形式 在印度次大陆以及全球儿科人口中的演讲 地方性地区，以及美国等非流行地区）。仍然是最佳可用的功效 治疗疗法在实质脑NCC中的功效低于70％，具有一到两个病变。最近 牛津唑（Oxf）作为人类使用的潜在抗寄生虫的发展可能会提供新的， 实用工具具有提高功效和更容易给药的实用工具。我们将执行三臂双盲， 在两个不同地理区域的六个中心的随机对照试验，三个在印度，三个 秘鲁，评估OXF的单剂量状态是否与当前使用的疗效相当 ABZ Plus PZQ的10天政权，以及3剂的OXF是否可以提供增加的寄生虫 功效。研究队列还将允许识别可能预测病变的早期成像标记 响应抗寄生虫治疗的解决方案，并将提供有关口服oxf安全性的其他数据 以及与该人群中残留疤痕，癫痫发作复发或生活质量降低相关的因素。 最后，在队列中的系统采样将提供DNA，白细胞，血清的定义电池 和尿液样本，用于对单质膜实质NCC诊断测定的未来评估。