NCT03084783UnknownPhase 3
Dexamethasone in Herpes Simplex Virus Encephalitis Open Label Randomized Controlled Trial With an Observer-blinded Evaluation at 6 Months
University Hospital, Grenoble8 sites in 1 country30 target enrollmentStarted: November 1, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 30
- Locations
- 8
- Primary Endpoint
- Calcul of verbal memory score
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group
Experimental
Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Intervention: Dexamethasone (Drug)
Outcomes
Primary Outcomes
Calcul of verbal memory score
Time Frame: at 6 months post randomization
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.
Secondary Outcomes
- Incidence of epilepsy(during 18 months)
- Anti NMDA receptor antibody testing(at 6 months)
- Quality of Life measured by SF-36 questionnaires(at 6 and 18 months)
- Visual Memory Index assessed by the Wechsler Memory Scale(6 months and 18 months post randomization)
- Processing Working Memory - assessed by the Wechsler Adult Intelligence Scale version IV(6 months and 18 months post randomization)
- Anxiety -assessed by self-completed Beck Anxiety Inventory(6 months and 18 months post randomization)
- Higher executive function -assessed by Trail Making Test Parts A and B(6 months and 18 months post randomization)
- Depression -assessed by self-completed Beck Depression Inventory Inventory(6 months and 18 months post randomization)
- Cognitive Assessment assessed by Addenbrooke's Cognitive Assessment revised (ACE-III)(at 30 days/discharge, 6 and 18 months)
- Requirement of intensive care or high dependency admission(during 18 months)
- Time to recovery of Glasgow Coma Scale (GCS)(during 18 months)
- Transcriptomic and proteomic profiling on CSF(at baseline and 2 weeks)
- Proportion of patients with detectable HSV in CSF(at 2 weeks)
- Health Status Measured by the EuroQOL-5D-5L questionnaire(at 6 and 18 months)
- Measurement of temporal lobe volume (as % of intra-cranial volume)(Baseline, 2 weeks, 6 months and 18 months)
- Measurement of Whole brain volume (as % of intra-cranial volume)(Baseline, 2 weeks, 6 months and 18 months)
- Transcriptomic and proteomic profiling on blood(at baseline, 4 days, 2 weeks, and 6 months)
Investigators
Study Sites (8)
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