A phase III multicentre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the management of children with encephalitis (The IgNiTE study)

niversity of Oxford0 sites18 target enrollmentJune 24, 2015

Overview

Registry

who.int

Start Date

June 24, 2015

End Date

July 31, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. 6 weeks to 16 years of age (day before 17th birthday)
•2\. Acute (within 24 hours) or subacute (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:
•3\.1\. Fever \>38oC within 72 hours before or after presentation to hospital
•3\.2\. Brain imaging evidence consistent with encephalitis or immune\-mediated encephalopathy that is either new from prior studies or appears acute in onset
•3\.3\. CSF pleocytosis \>4 white blood cells (WBCs)/microlitre
•3\.4\. Generalised or partial seizures not fully attributable to a preexisting seizure disorder
•3\.5\. New onset focal neurological signs (including movement disorders) for \>6 hours
•3\.6\. 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)

•1\. 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)
•2\. Receipt of any IVIg product during the index admission where this was administered prior to obtaining written informed consent for the IgNiTE study
•3\. Traumatic brain injury
•4\. Known metabolic encephalopathy
•5\. Toxic encephalopathy (i.e. encephalopathy secondary to exposure to intoxicants, including alcohol, prescription or recreational drugs)
•6\. Hypertensive encephalopathy/posterior reversible encephalopathy syndrome
•7\. Preexisting demyelinating disorder; preexisting antibody mediated CNS disorder; preexisting CSF diversion
•8\. Ischaemic or haemorrhagic stroke
•9\. Children with a contraindication to IVIG or albumin (i.e. history of anaphylactic reaction to IVIG or albumin, known IgA deficiency and history of hypersensitisation)
•10\. Known hypercoagulable state