Informations générales (source: ClinicalTrials.gov)
Dexamethasone in Herpes Simplex Virus Encephalitis Open Label Randomized Controlled Trial With an Observer-blinded Evaluation at 6 Months (DexEnceph)
Interventional
Phase 3
University Hospital, Grenoble (Voir sur ClinicalTrials)
novembre 2018
décembre 2020
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| IFSI-IFAS DU CH BICHAT-CLAUDE BERNARD | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHRU de Nancy, Hopitaux de Brabois - 54511 - Vandoeuvre Les Nancy - France | Contact (sur clinicalTrials) | ||||
| CHU Hôtel-Dieu - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| CHU Strasbourg - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hôpital Charles Nicolle - 76031 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Hôpital Gui de Chauliac - 34295 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU Rennes, Hôpital Pontchaillou - 35000 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Hôpital Delafontaine - 93205 - Saint-Denis - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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