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Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis

NCT02308982 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-03-04

No results posted yet for this study

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 objective is to find out whether early use of IVIG treatment improves neurological outcomes of children with encephalitis.

308 children with encephalitis, aged 6 weeks to 16 years will be recruited in 30 hospitals in the United Kingdom. Participants will be randomised to receive two doses of IVIG or matching placebo in addition to other standard treatments, within the first five days of hospital admission.

Each participant will be followed up for 12 months. During this period, information on clinical, radiological and laboratory investigations will be collected. Neurological outcomes will be assessed by the use of questionnaires at 6 and 12 months, and a neuropsychological assessment at 12 months.

Conditions

Interventions

DRUG

Immunoglobulins, Intravenous (Privigen)

DRUG

Placebo

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • CSL Behring

    collaborator INDUSTRY

  • University of Liverpool

    collaborator OTHER

  • University College London Hospitals

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • Liverpool University Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    collaborator OTHER

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew J Pollard, FRCPCH, PhD · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02308982 on ClinicalTrials.gov