PER-001-16尚未招募未知
A RANDOMIZED TRIAL OF COMBINED ALBENDAZOLE PLUS PRAZIQUANTEL FOR SUBARACHNOID CYSTICERCOSIS OF THE SYLVIAN FISSURE OR THE BASAL CISTERNS
IVERSIDAD PERUANA CAYETANO HEREDIA,0 个研究点目标入组 0 人开始时间: 2016年5月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65（—）
入选标准
- •- Male or female adult individuals (18 to 65 y.o.) with a diagnosis of basal subarachnoid cysticercosis (including locations in the Sylvian fissure or lower interhemispheric spaces) by neuroimaging and confirmed by serology.
- •- Baseline laboratory results along acceptable ranges (specifically defined in the study protocol).
- •- Willingness to accomplish the two-week minimum hospitalization required.
- •Patients will be considered eligible for the study if they have NCC involving the basal cisterns, the interhemispheric brain space, or the Sylvian fissure on baseline CT or MRI. Patients with only small subarachnoid lesions (<20mm in diameter) in the convexity of the brain hemispheres will not be included because these lesions commonly respond well to therapy and behave as intraparenchymal lesions.
排除标准
- •- Previous therapy with ABZ or PZQ in the preceding 3 years (except for patients who received single-dose ABZ for intestinal parasites, or patients who received antiparasitic treatment between one and three years before enrollment but demonstrated lesion persistence or progression during the past 12 months).
- •- A type of NCC which can expose the patient to increased risk during the study, specifically: a) intraventricular cysts; b) cysts in brainstem; c) concomitant intraparenchymal lesions greater than 3 cm of diameter in addition to their SANCC lesions; d) more than 20 intraparenchymal cysts in addition to their SANCC lesions; or d) untreated ocular cysticercosis. Patients with a lateral ventricle cyst, less than 2 cm in diameter, without hydrocephalus or intracranial hypertension, can be included. The presence of concomitant intraparenchymal cysts of less than 3 cm in diameter will not exclude the patient unless there are more than 20 of them.
- •- Active pulmonary tuberculosis evidenced by positive 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.
- •- Systemic disease that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, and steroid-dependent immune diseases.
- •- Patients in unstable condition or with symptomatic intracranial hypertension (ICH). Definition of symptomatic ICH for this study is the presence of headaches, nausea, and vomiting, with papilledema at fundoscopic examination. Patients in this category can be considered for entrance into the study only after resolution of ICH by ventricular-peritoneal shunting or neuroendoscopic procedures involving CSF flow derivation.
- •- Pregnancy during anti-parasitic treatment. If a patient becomes pregnant after treatment, she will continue in the study but will have radiological exams delayed until after delivery.
- •- History of hypersensitivity to ABZ or PZQ
- •- Chronic alcohol or drug abuse as defined in the study protocol.
- •- Unwilling or unable to undergo MRI exams (like patients with ferromagnetic implants)
- •- Inability or unwillingness of subject or legal representative to give written informed consent.
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