NCT03144570

Brief Summary

Prospective observational multicenter study in European ICUs. All patients admitted to the ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of America criteria) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
596

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Typical duration for all trials

Geographic Reach
6 countries

65 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2017

Completed
23 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

3.1 years

First QC Date

May 3, 2017

Last Update Submit

March 29, 2021

Conditions

Keywords

ICU, encephalitis, meningo-encephalitis, seizures

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin scale score

    The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It has become the most widely used clinical outcome measure for stroke clinical trials.

    Day 90

Secondary Outcomes (5)

  • Mortality at Day 28

    Day 28

  • Systematic complications

    Day 90

  • Intracranial complications

    Day 90

  • Intracranial pressure monitoring

    Day 90

  • Neurosurgery

    Day 90

Interventions

Not applicable, non-interventional study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1000 patients admitted to the ICU for AE (5 consecutive patients in each participating ICU, targeted number of ICUs in Europe : 200).

You may qualify if:

  • Age ≥ 18 years
  • non-opposition to participate in the study (or consent if applicable according to local legislation)
  • Impaired consciousness (altered mentation, stupor, or personality changes) for a duration ≥ 24 h, without obvious explanation
  • A score on the Glasgow Coma Scale \< or =13 at ICU admission
  • A Cerebrospinal fluid pleocytosis \> = 5 cell / mm3
  • At least 2 of the following :
  • Fever (≥ 38.0 °C) within 72 hours before or after admission
  • Generalized or partial seizures non-attributable to pre-existing epilepsy
  • New onset focal neurological deficit
  • Parenchymal abnormalities on MRI compatible with AE
  • EEG alterations compatible with AE.

You may not qualify if:

  • CSF or neuroimaging not available (s) or not performed.
  • febrile encephalopathy associated with another diagnosis (sepsis, neurological disease with aspiration pneumonia ... )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (65)

Medical University of Innsbruck

Innsbruck, Austria

Location

Centre Hospitalier d'Angoulême

Angoulême, 16000, France

Location

Centre Hospitalier Annecy Genevois

Annecy, 74370, France

Location

Hôpital Victor Dupouy

Argenteuil, 95107, France

Location

Hôpital Ambroise Paré

Boulogne-Billancourt, 92104, France

Location

CHU Brest

Brest, 29200, France

Location

Hôpital Pierre Wertheimer

Bron, 69677, France

Location

Centre Hospitalier René Dubos

Cergy-Pontoise, 95303, France

Location

CH de Charlesville-Mézières

Charleville-Mézières, 08011, France

Location

Les Hôpitaux de Chartres

Chartres, 28018, France

Location

Centre Hospitalier Châlons en Champagne

Châlons-en-Champagne, 51000, France

Location

Centre Hospitalier Public du Cotentin

Cherbourg, 50100, France

Location

Hôpital Antoine Béclère

Clamart, 92140, France

Location

CHU Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

APHP Colombes - Louis Mourier

Colombes, 92701, France

Location

Centre Hospitalier du Sud Francilien

Corbeil-Essonnes, 91160, France

Location

Hôpitaux Universitaires Henri Mondor

Créteil, 94000, France

Location

Centre hopsitalier de Dieppe

Dieppe, 76200, France

Location

Centre hospitalier Sud Essone

Étampes, 91150, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

Marne la Vallée - Meaux

Jossigny, 77600, France

Location

CH Vendée

La Roche, 85925, France

Location

CH du Mans

Le Mans, 72037, France

Location

Hôpital R Salengro

Lille, 59000, France

Location

Centre Hospitalier Lorient

Lorient, 56322, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

Hôpital de la Timone

Marseille, 13385, France

Location

CHU Hôpital Nord

Marseille, 13915, France

Location

CHR Metz-Thionville

Metz, 57085, France

Location

CHU Lapeyronie

Montpellier, 34090, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hôpital de la Source

Orléans, 45100, France

Location

Hôpital Saint Louis

Paris, 75010, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Hôpital Européen Georges-Pompidou

Paris, 75015, France

Location

Hôpital Bichat Claude Bernard

Paris, 75018, France

Location

Hôpitaux universitaires Est Parisien, Tenon

Paris, 75020, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75104, France

Location

Groupe hospitalier Pitié-Salpêtrière

Paris, 75651, France

Location

Fondation Opthalmologique Adolphe de Rothschild

Paris, 75940, France

Location

Centre Hospitalier de Pau

Pau, 64000, France

Location

Centre Hospitalier Intercommunal de Poissy

Poissy, 78303, France

Location

CHU Rennes

Rennes, 35033, France

Location

CH Roanne

Roanne, France

Location

Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE

Saint-Denis, 93200, France

Location

CHU de Toulouse Purpan

Toulouse, 31300, France

Location

Centre hospitalier de Tourcoing

Tourcoing, 59200, France

Location

Hôpital André Mignot

Versailles, 78150, France

Location

CH des 2 vallées, Site Longjumeau

Longjumeau, Île-de-France Region, 91160, France

Location

Ims & Sum Hospital

Bhubaneswar, India

Location

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, 226014, India

Location

Institute Of Medical Sciences Banaras Hindu University

Lucknow, India

Location

King George's medical university

Lucknow, India

Location

Sri Ramachandra Institute of Higher Education and Research

Lucknow, India

Location

Azienda USL Toscana Centro

Florence, Italy

Location

San Gerardo Hospital

Monza, 20900, Italy

Location

Università Cattolica del Sacro Cuore

Roma, 00168, Italy

Location

Academic Medical Center

Amsterdam, 1105, Netherlands

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de la Santa Creu

Barcelona, 08041, Spain

Location

Germans Trias i Pujol

Barcelona, 08916, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, 28222, Spain

Location

Complexo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

Location

Hospital Universitari Arnau de Vilanova

Zaragoza, Spain

Location

Related Publications (1)

  • Sonneville R, de Montmollin E, Contou D, Ferrer R, Gurjar M, Klouche K, Sarton B, Demeret S, Bailly P, da Silva D, Escudier E, Le Guennec L, Chabanne R, Argaud L, Ben Hadj Salem O, Thyrault M, Frerou A, Louis G, De Pascale G, Horn J, Helbok R, Geri G, Bruneel F, Martin-Loeches I, Taccone FS, De Waele JJ, Ruckly S, Staiquly Q, Citerio G, Timsit JF; EURECA Investigator Study Group. Clinical features, etiologies, and outcomes in adult patients with meningoencephalitis requiring intensive care (EURECA): an international prospective multicenter cohort study. Intensive Care Med. 2023 May;49(5):517-529. doi: 10.1007/s00134-023-07032-9. Epub 2023 Apr 6.

MeSH Terms

Conditions

EncephalitisSeizures

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean François Timsit

    ICUREsearch

    STUDY CHAIR
  • Romain Sonneville

    Hôpital Bichat, APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 9, 2017

Study Start

June 1, 2017

Primary Completion

July 6, 2020

Study Completion

December 31, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations