An Open-label Non-randomized Phase IIa Trial to Evaluate Safety of Early Intervention in Asymptomatic Subarachnoid Neurocysticercosis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Safety; severe adverse events
研究概览
简要总结
Subarachnoid neurocysticercosis (SANCC) is a severe infection of the brain by the tapeworm Taenia solium. People who have this infection are usually diagnosed late in the disease process leading to very poor prognosis. This trial studies the safety of early medical intervention in people who have SANCC but do not have symptoms. The trial will enroll 18 participants in Peru.
详细描述
PRIMARY OBJECTIVE:
I. To estimate the risk of serious adverse events (SAE) related to intervention in asymptomatic SANCC; these include drug-related side effects, moderate/severe intracranial hypertension, hydrocephalus requiring shunting or endoscopy, stroke, status epilepticus, or unexplained death.
OUTLINE:
Participants will be hospitalized for approximately 15-30 days while they receive treatment with the antiparasitic drug albendazole, as well as additional drugs (dexmathesaone and omeprazole) to address potential treatment complications. Participants will have continuous monitoring for adverse events while in the hospital. After participants are released to home, they will monitored for adverse events for an additional 12 months through home visits, telephone contact, and monthly clinical evaluations with serologic and radiologic assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female individuals older than two years with a diagnosis of asymptomatic SANCC confirmed by MRI.
- •SANCC limited to the basal cisterns, the interhemispheric brain space, brain fissures or spine.
- •Baseline laboratory results within acceptable ranges (specifically defined in the study protocol)
- •Willingness to accomplish the two-week minimum hospitalization required.
排除标准
- •Individuals who only have subarachnoid lesions in the convexity of the brain hemispheres will not be included because these lesions commonly respond well to therapy and behave as intraparenchymal lesions
- •Co-occurrence of a) more than 20 intraparenchymal lesions in addition to their subarachnoid disease, or b) intraparenchymal lesions greater than 3.0 cm of diameter
- •Individuals for whom a surgical intervention to treat their subarachnoid disease is considered clearly superior to a medical intervention
- •Previously diagnosis or treatment for cysticercosis.
- •Active pulmonary tuberculosis evidenced by chest X-ray and positive sputum smears, or symptoms compatible with tuberculosis (fever+sweats or fever+cough) not otherwise explained
- •Individuals with positive markers for active hepatitis
- •Other systemic disease that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, or steroid-dependent immune diseases
- •Pregnancy. If a participant becomes pregnant during the study, she will continue in the study but will have radiological exams delayed until after delivery
- •History of hypersensitivity to ABZ
- •Chronic alcohol or drug abuse as defined in the study protocol
- •Unwilling or unable to provide MRI exams (e.g. patients with ferromagnetic implants)
- •Inability or unwillingness of subject or legal representative to give written informed consent.
研究组 & 干预措施
Medical intervention
Participants are hospitalized for 15-30 days while they receive the antiparasitic drug albendazole along with supportive drugs including dexamethasone and omeprazole.
干预措施: Albendazole (Drug)
结局指标
主要结局
Safety; severe adverse events
时间窗: The 3 month period directly following the intervention
Proportion of subjects that experience any severe adverse event that is directly related to the treatment intervention
次要结局
- Safety; all adverse events(The 12 month period directly following the intervention)
- Diagnostic; antigen levels(Months 3,6,9, and 12 after intervention)
研究者
Seth E O'Neal, MD MPH
Assistant professor
Oregon Health and Science University