NCT02906631: ENCEPHALITICA

Epidemiology and Prognosis of Encephalitis in Intensive Care

Completed Last updated 20 March 2024

What this trial tests

trial in Encephalitis in 350 participants. Completed in 1 December 2023.

Timeline

27 October 2017

Primary endpoint
20 April 2023

1 December 2023

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Status	Completed
Study type	OBSERVATIONAL
Enrollment	350
Start date	27 October 2017
Primary completion	20 April 2023
Estimated completion	1 December 2023
Sites	1 location across France

Conditions studied

• Encephalitis — all drugs for Encephalitis →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Encephalitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction: Acute encephalitis (AE) is a severe neurological disorder associated with significant morbidity and mortality. Approximately 50% of patients with AE require ICU admission because of coma, seizures or acute respiratory failure. Determinants of neurological prognosis in these patients are not known.

Objectives:

Main objective: To identify determinants of outcome in adult patients admitted to the ICU; Secondary objectives: a) To study the impact of diagnostic studies (Brain MRI, CSF analysis, EEG) on neurologic outcome; b) to describe the epidemiology of patients admitted to the ICU with AE; c) to study the impact of early appropriate therapy on neurologic outcomes; d) to describe morbidity and mortality associated with AE at 90 days and 1 year following diagnosis.

Methods: prospective observational multicenter study in French ICUs. All patients admitted to the ICU for probable or confirmed AE (2013 IDSA criteria)with a Glasgow coma scale score \< or =to 13 will be eligible for inclusion. Factors associated with a poor prognosis at 90 days will be identified by multivariable logistic regression analysis.

Duration of study: 30 months (recruitment 18 months, follow-up 12 months).

Patients: 300 patients

Endpoints:

* Primary endpoint: The primary endpoint is the modified Rankin scale score 90 days following onset of abnormal status (GCS \< or =13). This score will be determined by contacting the patient. A poor outcome will be defined as a mRS \>2 at 90 days.
* Secondary endpoints: a) neurological findings within 7 days following onset of altered mental status; b) abnormal findings on diagnostic studies (MRI, EEG, CSF analysis) within7 days following onset of altered mental status; c) Time between onset of altered mental status and completion of diagnostic studies; d)Time between onset of altered mental status and start of appropriate specific therapy; e) neurologic outcomes at 1 year mRS score and extended Glasgow outcome scale (GOS); f) causes of death in non-survivors at 1 year; g) quality of life and posttraumatic stress at 1 year: IADL and SF36 scales;

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Outcomes of Critically Ill Adult Patients With Acute Encephalitis.
   Sonneville R, Couffignal C, Souweine B, Demiri S, et al · · 2025 · cited 1× · PMID 40965884 · DOI 10.1001/jamanetworkopen.2025.32478