Dexamethasone in Herpes Simplex Virus Encephalitis

Last updated: September 3, 2020
Sponsor: University Hospital, Grenoble
Overall Status: Active - Recruiting

Phase

3

Condition

Memory Loss

Treatment

N/A

Clinical Study ID

NCT03084783
38RC16.015
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Suspected encephalitis criteria: Acute or subacute (up to 4 weeks) alteration inconsciousness, cognition, personality or behaviour* persisting for > 24 hours Laboratoryconfirmed HSV by positive PCR on CSF sample.

  • Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renalimpairment

  • Age ≥ 18 years

  • Person affiliated to social security

  • Written informed consent has been given by the patient or their legal representative

Exclusion

Exclusion Criteria:

  • Currently receiving oral or injectable corticosteroid therapy; including treatmentwith 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 previousendoscopy 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

Study Design

Total Participants: 30
Study Start date:
November 01, 2018
Estimated Completion Date:
December 01, 2020

Connect with a study center

  • Hôpital Gui de Chauliac

    Montpellier, 34295
    France

    Active - Recruiting

  • CHU Hôtel-Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • Hôpital Bichat-Claude Bernard, APHP

    Paris, 75877
    France

    Active - Recruiting

  • CHU Rennes, Hôpital Pontchaillou

    Rennes, 35000
    France

    Active - Recruiting

  • Hôpital Charles Nicolle

    Rouen, 76031
    France

    Active - Recruiting

  • Hôpital Delafontaine

    Saint-Denis, 93205
    France

    Active - Recruiting

  • CHU Strasbourg

    Strasbourg, 67091
    France

    Active - Recruiting

  • CHRU de Nancy, Hopitaux de Brabois

    Vandoeuvre Les Nancy, 54511
    France

    Active - Recruiting

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