Status:
COMPLETED
Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
CSL Behring
Conditions:
Encephalitis
Eligibility:
All Genders
6-16 years
Phase:
PHASE3
Brief Summary
This is a phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the treatment of children with encephalitis. The primary objecti...
Detailed Description
Encephalitis is a syndrome of neurological dysfunction caused by inflammation of the brain parenchyma, resulting in altered mental status, seizures, and/or focal neurologic deficits, usually accompani...
Eligibility Criteria
Inclusion
- 6 weeks to 16 years of age (day before 17th birthday) AND
- 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 AND
- At least two of:
- fever \> 38 degrees Celsius within 72 hours before or after presentation to hospital
- brain imaging evidence consistent with encephalitis or immune-mediated encephalopathy that is either new from prior studies or appears acute in onset
- CSF pleocytosis \> 4 white blood cells per microlitre
- generalised or partial seizures not fully attributable to a pre-existing seizure disorder
- new onset focal neurological signs (including movement disorders) for \> 6 hours
- abnormality on EEG that is consistent with encephalitis and not clearly attributable to another cause AND
- Parent/guardian/legal representative able to give informed consent
Exclusion
- 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 contra-indication to IVIG or albumin (i.e. history of anaphylactic reaction to IVIG or albumin, 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 being actively followed up in another research trial involving an investigational medicinal product
- Administration of study drug not feasible within 120 hours from 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 includes plans to be outside the UK for more than 12 months after enrolment)
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02308982
Start Date
January 1 2016
End Date
September 1 2022
Last Update
March 4 2024
Active Locations (25)
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1
Grampian Health Board
Aberdeen, United Kingdom, AB15 6RE
2
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom, B4 6NH
3
Heart of England NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
4
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom