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临床试验/NCT00001205
NCT00001205招募中不适用

Natural History of Treated Neurocysticercosis and Long-Term Outcomes

National Institute of Allergy and Infectious Diseases (NIAID)1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 1999年11月4日最近更新:
适应症

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

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)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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