Dexamethasone in Herpes Simplex Virus Encephalitis

University Hospital, Grenoble30 enrolled

Overview

Encephalitics is a serious condition in which the brain becomes inflamed (swollen). It usually happens as a direct result of virus, such as herpes simplex virus (HSV). HSV encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the growth and spread of HSV in the body). Despite this however, around 2 out of every 3 people will have memory difficulties long term. Dexamethasone is a corticosteroid medication, which works by preventing the release of natural chemicals in the body which cause inflammation. It is possible that dexamethasone could help to reduce in swelling of the brain may improve the recovery of patients with HSV encephalitis. The aim of this study is to find out whether treatment with dexamethasone can improve long-term health outcomes in adults with HSV Encephalitis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

HSV Encephalitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Suspected encephalitis criteria: Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour\* persisting for \> 24 hours Laboratory confirmed HSV by positive PCR on CSF sample. * Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment * Age ≥ 18 years * Person affiliated to social security * Written informed consent has been given by the patient or their legal representative Exclusion Criteria: * Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days. * History of hypersensitivity to corticosteroids * Immunosuppression secondary to: * Known HIV infection \& CD4 count under 200cell/mm3 * Biologic therapy or other immunosuppressive agents \[azathioprine, methotrexate, ciclosporin\] * Solid organ transplant on immunosuppression * Bone marrow transplant * Currently undergoing a course of chemotherapy or radiotherapy * Known immunodeficiency syndrome \[other than HIV\] * Known haematological malignancy * Pre-existing indwelling ventricular devices * Peptic ulcer disease in the last 6 months: defined as a peptic ulcer seen at previous endoscopy or an upper gastrointestinal bleed causing ≥ 2 unit haemoglobin drop * Currently on an antiretroviral regime containing rilpivirine * Patients under legal protection, administrative or judicial control * Pregnancy / Breast feeding and parturient * Subject in exclusion period of another study

Locations (8)

Hôpital Gui de Chauliac

Montpellier, France

RECRUITING

CHU Hôtel-Dieu

Nantes, France

RECRUITING

Hôpital Bichat-Claude Bernard, APHP

Paris, France

RECRUITING

CHU Rennes, Hôpital Pontchaillou

Rennes, France

RECRUITING

Hôpital Charles Nicolle

Rouen, France

RECRUITING

Hôpital Delafontaine

Saint-Denis, France

RECRUITING

CHU Strasbourg

Strasbourg, France

RECRUITING

CHRU de Nancy, Hopitaux de Brabois

Vandœuvre-lès-Nancy, France

RECRUITING

Outcomes

Primary Outcomes

Calcul of verbal memory score

The primary outcome is a verbal memory score as determined by the Wechsler Memory Scale (WMS-IV) Auditory Memory Index, at 6 months post randomisation.

Time frame: at 6 months post randomization