EUCTR2014-002997-35-GB进行中（未招募）不适用
A phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the management of children with encephalitis (The IgNiTE study) - IgNiTE: Immunoglobulin in the treatment of encephalitis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 308
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) 6 weeks to 16 years of age (day before 17th birthday)
- •2) Acute (within 24 hours) or sub-acute (between 24 hours and 4 weeks) onset of altered mental state (reduced or altered conscious level, irritability, altered personality or behaviour, lethargy) not attributable to a metabolic cause
- •3) At least two of:
- •(a) fever >38oC within 72 hours before or after presentation to hospital
- •(b) brain imaging evidence consistent with encephalitis or immune-mediated
- •encephalopathy that is either new from prior studies or appears acute in onset
- •(c) CSF pleocytosis >4 white blood cells (WBCs)/microlitre
- •(d) generalised or partial seizures not fully attributable to a pre-existing
- •seizure disorder
- •(e) new onset focal neurological signs (including movement disorders) for >6 hours
- •(f) abnormality on EEG that is consistent with encephalitis and not clearly
- •attributable to another cause.
- •4) Parent/guardian/ legal representative/child (if 16 years at the time of enrolment and has capacity to give consent) able to give informed consent and assent (if <16 years and has capacity)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 308
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •high clinical suspicion of bacterial meningitis or TB meningitis (for example: presence of frankly
- •purulent CSF; CSF WBCs >1000/microlitre; bacteria on Gram stain and/or culture)
- •Traumatic brain injury
- •Known metabolic encephalopathy
- •Toxic encephalopathy (i.e. encephalopathy secondary to exposure to intoxicants, including alcohol,prescription or recreational drugs)
- •hypertensive encephalopathy/posterior reversible encephalopathy syndrome
- •pre-existing demyelinating disorder; pre-existing antibody mediated CNS disorder; pre-existing CSF diversion
- •ischaemic or haemorrhagic stroke
- •children with a contraindication to IVIG or albumin (i.e. history of anaphylactic reaction to either products, known IgA deficiency and history of hypersensitisation)
- •Known hypercoagulable state
- •significant renal impairment defined as GFR of 29mls/min/1.73m2 and below (Chronic Kidney
- •Disease Stage 4)
- •Known hyperprolinaemia
- •Known to be pregnant
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the
- •participant’s ability to participate in the trial
- •participants who are actively being followed up in another research trial involving an investigational product thought to
- •have an immunomodulatory or neuroprotective effect
- •Administration of study drug not feasible within 120 hours of hospital admission as determined by the study team
- •Any other condition which, in the opinion of the investigator, may interfere with the ability to fulfil study requirements, especially relating to the primary objective of the study (this include plans to be outside the UK for more than 12 months after enrolment)
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