ISRCTN69615004进行中（未招募）3 期
Intravenous immunoglobulin in autoimmune encephalitis in adults – a randomised double-blind placebo-controlled trial
niversity of Liverpool0 个研究点目标入组 356 人开始时间: 2021年3月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 356
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/03/2024:
- •1. Adults (=16 years) with altered consciousness level AND/OR behavioural change AND/OR working memory deficit AND/OR psychiatric symptoms
- •2. Persisting for >24 hours and <12 months but no more than 3 months since diagnosis
- •3. In whom clinician thinks autoimmune encephalitis is the most likely diagnosis
- •4. CSF polymerase chain reaction (PCR) negative for HSV 1 and 2, and varicella zoster virus
- •5. CSF microscopy and culture-negative at 48 hours for organisms
- •PLUS two or more of:
- •1. Seizures (not explained by previously known seizure disorder) OR new movement disorder
- •2. Cerebrospinal fluid (CSF) white blood cell count 6-1000/mm³
- •3. Electroencephalogram consistent with encephalitis
- •4. Brain magnetic resonance imaging (MRI) or computer tomography (CT) changes consistent with encephalitis (including normal scan)
- •Previous inclusion criteria:
- •1. Adults (=16 years) with altered consciousness level AND/OR behavioural change AND/OR working memory deficit AND/OR psychiatric symptoms
- •2. Persisting for >24 hours and <3 months
- •3. In whom clinician thinks autoimmune encephalitis is the most likely diagnosis
- •4. CSF polymerase chain reaction (PCR) negative for HSV 1 and 2, and varicella zoster virus
- •5. CSF microscopy and culture-negative at 48 hours for organisms
- •PLUS two or more of:
- •1. Seizures (not explained by previously known seizure disorder) OR new movement disorder
- •2. Cerebrospinal fluid (CSF) white blood cell count 6-1000/mm³
- •3. Electroencephalogram consistent with encephalitis
- •4. Brain magnetic resonance imaging (MRI) or computer tomography (CT) changes consistent with encephalitis
排除标准
- •1. No other likely diagnosis
- •2. Current or recent (within last 6 months) treatment with IVIG
- •3. Contraindication to IVIG
- •4. Intolerance of corticosteroids
- •5. Recent history of gastric ulcers
- •6. CSF analysis not performed
- •7. CSF polymerase chain reaction (PCR) positive for any viruses
- •8. Brain imaging not performed
- •9. Alternative diagnosis on brain imaging (CT or MRI)
- •10. Known HIV infection
- •11. On steroids or other disease-modifying anti-inflammatory therapies
- •12. Not able to live independently prior to onset of condition
研究者
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