Dexamethasone in Herpes Simplex Virus Encephalitis (DexEnceph)

Grenoble Alpes University Hospital Center (CHU)

Status and phase

Unknown

Phase 3

Conditions

HSV Encephalitis

Treatments

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT03084783

38RC16.015

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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