ISRCTN15791925CompletedPhase 3
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)
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- niversity of Oxford
- Enrollment
- 18
Study Overview
Brief Summary
2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27810972 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37945292/ (added 13/11/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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)
Exclusion Criteria
- •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
- •11. Significant renal impairment defined as GFR of 29mls/min/1.73m2 and below (Chronic Kidney Disease Stage 4)
- •12. Known hyperprolinaemia
- •13. Known to be pregnant
- •14. 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
- •15. Participants who are being actively followed up in another research trial involving an investigational medicinal product
- •16. Administration of study drug not feasible within 120 hours from hospital presentation for the index admission for new patients admitted to a study hospital OR 72 hours from admission to the study hospital for patients transferred from other hospitals, as determined by the study team
- •17. 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 includes plans to be outside the UK for more than 12 months after enrolment)
Investigators
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