Natural History of Treated Neurocysticercosis and Long-Term Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
研究概览
简要总结
Neurocysticercosis is a brain disease due to the larval stage of the pork tapeworm (Taenia solium). The most common symptoms patient experience from infection inside the substance of the brain (parenchymal disease) are seizures and headaches. When the infection is either inside the fluid pockets inside the brain (ventricular disease) or in the space around the brain (subarachnoid disease) patients can have chronic headaches, relapsing aseptic meningitis, hydrocephalus, stroke, and may require neurosurgical intervention. The purpose of this study is to treat patients with anthelmintic therapy (praziquantel and/or albendazole) and anti-inflammatories in alignment with currently accepted best practices and guidelines, depending on the neurocysticercosis subtype. The purpose of the study is to better understand and characterize clinical, biologic, and management factors during treatment that influence long term outcomes. In order to understand this further we collect patient clinical information, patient survey responses, blood, urine samples, and additional cerebral spinal fluid if already being collected for clinical care.
详细描述
Study Description:
The purpose of this protocol is to follow participants with cysticercosis during and after completion of treatment, to characterize the disease course during both short- and long-term follow-up, assess biomarkers associated with infection and response to treatment, improve diagnostic assays, and explore host-parasite interactions.
Primary Objective:
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
Secondary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 99 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •Arms 1-5 (NCC):
- •Aged 3 years and older.
- •Ability of participant (or legally authorized representative, LAR) to understand and the willingness to sign a written informed consent document.
- •Patients with proven or likely NCC
- •Arm 6 (Endemic Exposures):
- •Patient with epidemiologic history compatible with possible exposure to NCC
- •Aged 18 years and older.
排除标准
- •Not applicable
研究组 & 干预措施
Arm 3
Parenchymal cyst(s)--non-calcified parenchymal disease at time of referral
Arm 5
Calcified parenchymal disease without symptoms
Arm 6
Endemic exposure--subjects with compatible epidemiologic exposure to T. solium
Arm 1
Subarachnoid (racemose) neurocysticercosis
Arm 4
Calcified parenchymal disease with symptoms (seizures)
Arm 2
Ventricular without other viable disease
结局指标
主要结局
The primary objective is to characterize the biochemical and clinical course of neurocysticercosis (NCC) during and after treatment with long-term follow-up.
时间窗: Ongoing
To study the clinical course of cysticercosis following therapy and diminish morbidity associated with treatment of cysticercosis including neurocysticercosis or the inflammation associated with therapy
次要结局
- Central and peripheral immune cell phenotyping and cytokine measurements(2-5 years)
- Test known and novel biomarkers, serologic responses in the pre-clinical stage of neurocysticercosis, correlate findings with imaging.(2-5 years)
- Biobanking cerebrospinal fluid (CSF), serum, plasma, urine(Ongoing)
