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Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05605223
Collaborator
(none)
50
Enrollment
1
Location
42.2
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The number of acute encephalitides diagnosed each year is gradually increasing, reaching approximately 5 to 10/100,000 per year; more than 50% of etiologies currently remain unknown. The majority of them are acute encephalitis of infectious origin, but it is estimated that 20% of encephalitis in northern Europe is related to an autoimmune mechanism with the majority of encephalitis with anti-NMDA Ac discovered recently in 2007. The study of a large American encephalitis cohort showed a death rate of 3% to 7% in cases of autoimmune encephalitis. Furthermore, delay in the initiation of effective treatment (tumor removal or immunotherapy) beyond 4 weeks is associated with a poor prognosis at 1 year.

It is therefore necessary to better understand the signs of autoimmune encephalitis in order to recognize the disease quickly and to start a treatment quickly; in order to improve the management and the prognosis of these children.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Study of Acute Autoimmune Encephalitis With Positive Antibodies in Eastern France Between 2006 and 2018
    Actual Study Start Date :
    Jun 26, 2019
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Retrospective description of autoimmune encephalitis in children [Files analysed retrospectively from January 01, 2006 to December 31, 2018 will be examined]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Age between 0 and 17 years at diagnosis

    • Patient diagnosed between 01/01/2006 and 31/12/2018 with autoimmune encephalitis in one of the participating university hospitals (Besançon, Nancy, Strasbourg, Reims and Dijon)

    • Presence of clinical criteria of clinical and/or radiographic encephalitis

    • Presence of one or more antibodies in the blood or CSF

    • Parental authority holders and their child of childbearing age having given their consent for the use of the child's data for this research

    Exclusion criteria:

    • Refusal to participate in the study

    • Absence of consultation at any of the study centers

    • Absence of clinical and/or radiographic criteria for encephalitis.

    • Absence of antibodies found in blood or CSF

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05605223
    Other Study ID Numbers:
    • 7415
    First Posted:
    Nov 4, 2022
    Last Update Posted:
    Nov 4, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Acute autoimmune encephalitis
    encephalitis
    autoimmune encephalitis
    Additional relevant MeSH terms:
    Encephalitis
    Hashimoto Disease

    Study Results

    No Results Posted as of Nov 4, 2022