AzTrials
AzTrials

EncephalitisEURECANCT03144570

EURopean Study on Encephalitis in Intensive CAre

An observational study of Encephalitis, run by ICUREsearch at 65 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Encephalitis
What is being tested?
None, non-interventional study
How many people
596 participants
Where
65 sitesin 6 countries
Study dates
1 Jun 2017to 31 Dec 2020
How long will I take part?
3 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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 :
Show all 11Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

65 sites in 6 countries.

65 sites in 6 countries

France49 sites

  • Centre Hospitalier d'Angoulême

    Angoulême, 16000

  • Centre Hospitalier Annecy Genevois

    Annecy, 74370

  • Hôpital Victor Dupouy

    Argenteuil, 95107

  • Hôpital Ambroise Paré

    Boulogne-Billancourt, 92104

  • CHU Brest

    Brest, 29200

  • Hôpital Pierre Wertheimer

    Bron, 69677

  • Centre Hospitalier René Dubos

    Cergy-Pontoise, 95303

  • Centre Hospitalier Châlons en Champagne

    Châlons-en-Champagne, 51000

  • CH de Charlesville-Mézières

    Charleville-Mézières, 08011

  • Les Hôpitaux de Chartres

    Chartres, 28018

  • Centre Hospitalier Public du Cotentin

    Cherbourg, 50100

  • Hôpital Antoine Béclère

    Clamart, 92140

  • CHU Gabriel Montpied

    Clermont-Ferrand, 63000

  • APHP Colombes - Louis Mourier

    Colombes, 92701

  • Centre Hospitalier du Sud Francilien

    Corbeil-Essonnes, 91160

  • Hôpitaux Universitaires Henri Mondor

    Créteil, 94000

  • Centre hopsitalier de Dieppe

    Dieppe, 76200

  • Centre hospitalier Sud Essone

    Étampes, 91150

  • CHU Grenoble

    Grenoble, 38043

  • Marne la Vallée - Meaux

    Jossigny, 77600

  • CH Vendée

    La Roche, 85925

  • CH du Mans

    Le Mans, 72037

  • Hôpital R Salengro

    Lille, 59000

  • CH des 2 vallées, Site Longjumeau

    Longjumeau, Île-de-France Region, 91160

  • Centre Hospitalier Lorient

    Lorient, 56322

  • Hôpital Edouard Herriot

    Lyon, 69437

  • Institut Paoli-Calmettes

    Marseille, 13009

  • Hôpital de la Timone

    Marseille, 13385

  • CHU Hôpital Nord

    Marseille, 13915

  • CHR Metz-Thionville

    Metz, 57085

  • CHU Lapeyronie

    Montpellier, 34090

  • CHU de Nantes

    Nantes, 44093

  • Hôpital de la Source

    Orléans, 45100

  • Hôpital Saint Louis

    Paris, 75010

  • Hôpital Cochin

    Paris, 75014

  • Hôpital Européen Georges-Pompidou

    Paris, 75015

  • Hôpital Bichat Claude Bernard

    Paris, 75018

  • Hôpitaux universitaires Est Parisien, Tenon

    Paris, 75020

  • Groupe Hospitalier Paris Saint-Joseph

    Paris, 75104

  • Groupe hospitalier Pitié-Salpêtrière

    Paris, 75651

  • Fondation Opthalmologique Adolphe de Rothschild

    Paris, 75940

  • Centre Hospitalier de Pau

    Pau, 64000

  • Centre Hospitalier Intercommunal de Poissy

    Poissy, 78303

  • CHU Rennes

    Rennes, 35033

  • CH Roanne

    Roanne

  • Centre hospitalier de Saint-Denis, Hôpital DELAFONTAINE

    Saint-Denis, 93200

  • CHU de Toulouse Purpan

    Toulouse, 31300

  • Centre hospitalier de Tourcoing

    Tourcoing, 59200

  • Hôpital André Mignot

    Versailles, 78150

Other trials in France

Spain6 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital de la Santa Creu

    Barcelona, 08041

  • Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

  • Complexo Hospitalario Universitario de Ourense

    Ourense, 32005

  • Hospital Universitari Arnau de Vilanova

    Zaragoza

Other trials in Spain

India5 sites

  • Ims & Sum Hospital

    Bhubaneswar

  • Sanjay Gandhi Post Graduate Institute of Medical Sciences

    Lucknow, 226014

  • Institute Of Medical Sciences Banaras Hindu University

    Lucknow

  • King George's medical university

    Lucknow

  • Sri Ramachandra Institute of Higher Education and Research

    Lucknow

Other trials in India

Italy3 sites

  • Azienda USL Toscana Centro

    Florence

  • San Gerardo Hospital

    Monza, 20900

  • Università Cattolica del Sacro Cuore

    Roma, 00168

Other trials in Italy

Austria1 site

  • Medical University of Innsbruck

    Innsbruck

Other trials in Austria

Netherlands1 site

  • Academic Medical Center

    Amsterdam, 1105

Other trials in Netherlands

About this study

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.

Read the detailed description

Primary objective :

evaluate the correlation between mRs score and the baseline characteristics Functional outcomes will be evaluated using the modified Rankin score (mRS) score, which is one of the most frequently used scores in acute neurological diseases [18]. A poor outcome will be defined by a mRS score > 2 (functional dependence or death). The investigator usually evaluates this score if the patient is still in the hospital 90 days after admission. Patients discharged from hospital within 90 days following ICU admission without major disability (mRS 0, 1 or 2) are considered to have a good outcome. Patients discharged within 90 days with a disability will be classified for the study according to the latest available data. Patients will not be contacted directly by the investigator for the study purposes.

Secondary objectives :

To identify additional prognosis factors : the clinical, radiological, biological and neurophysiological factors associated with poor outcome for patients admitted to the ICU with AE

  • Day 28 mortality, in-ICU mortality, in-hospital mortality
  • Major systemic complications (septic shock, hyponatremia, nosocomial pneumonia, catheter-related BSI, overt gastroenteral bleeding, pulmonary embolism)
  • Major intracranial complications during ICU stay
  • Status epilepticus
  • Brain death
  • Empyema/cerebral abscess
  • Cerebral ischemia
  • Intracranial bleeding
  • ICP monitoring
  • Neurosurgery

The cause of death will be categorized into 2 categories:

  • Systemic causes (cardiovascular failure, MOF)
  • Neurological cause (Diffuse neurologic injury or withdrawal of care)
Conditions
Encephalitis
Being tested
None, non-interventional study
Keywords
ICU, encephalitis, meningo-encephalitis, seizures
Medical subject headings
Encephalitis, Seizures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None, non-interventional studyOther

    Not applicable, non-interventional study

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 90

Secondary outcomes (5)

  1. Mortality at Day 28

    Rate of death at day 28

    Measured: Day 28

  2. Systematic complications

    Septic shock, hyponatremia

    Measured: Day 90

  3. Intracranial complications

    Documented seizures, status epilepticus, Diffuse cerebral edema, herniation, Ischemia, cerebral hemorrhage

    Measured: Day 90

  4. Intracranial pressure monitoring

    List of all available methods of intracranial pressure monitoring used in study sites and their outcome

    Measured: Day 90

  5. Neurosurgery

    Monitoring of neurosurgery to identify additional prognosis factors

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study start1 Jun 2017
  3. Primary completion6 Jul 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
596 participants (actual)
Target duration
3 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03144570
Sponsor's protocol ID
0008
Acronym
EURECA
Status last verified
Mar 2021
First submitted
3 May 2017
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37022378

Questions about this trial

What is this clinical trial studying?

An observational study of Encephalitis, run by ICUREsearch at 65 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in France, Spain, India, Italy, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Rankin scale score (time frame: Day 90). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03144570, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in