Clinical Trial: Dexamethasone in Herpes Simplex Virus Encephalitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Dexamethasone in Herpes Simplex Virus Encephalitis : a Randomised Controlled Trial

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.


Detailed Summary:
Sponsor: University Hospital, Grenoble

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Visual Memory Index assessed by the Wechsler Memory Scale [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome
  • Processing Working Memory - assessed by the Wechsler Adult Intelligence Scale version IV [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome
  • Language -assessed by the confrontational naming task of the Language Module in the Neuropsychology Assessment Battery [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome
  • Higher executive function -assessed by Trail Making Test Parts A and B [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome
  • Premorbid cognitive ability - assessed by the Test of Premorbid Function (TOPF); [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome
  • Anxiety -assessed by self-completed Beck Anxiety Inventory [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome
  • Depression -assessed by self-completed Beck Depression Inventory Inventory [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome
  • 7. Participant's subjective cognitive complaints- assessed by the Perceived Deficits Questionnaire [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome
  • Cognitive Assessment assessed by Addenbrooke's Cognitive Assessment revised (ACE-III) [ Time Frame: at 30 days/discharge, 6 and 18 months ]
  • Requirement of intensive care or high dependency admission [ Time Frame: during 18 months ]
    clinical outcome
  • Time to recovery of Glasgow Coma Scale (GCS) [ Time Frame: during 18 months ]
    clinical outcome
  • Incidence of epilepsy [ Time Frame: during 18 months ]
    clinical outcome
  • Measurement of temporal lobe volume (as % of intra-cranial volume) [ Time Frame: Baseline, 2 weeks, 6 months and 18 months ]
    Imaging Outcomes
  • Measurement of Whole brain volume (as % of intra-cranial volume) [ Time Frame: Baseline, 2 weeks, 6 months and 18 months ]
    Imaging Outcomes
  • Transcriptomic and proteomic profiling on CSF [ Time Frame: at baseline and 2 weeks ]
    Biomarker outcomes
  • Transcriptomic and proteomic profiling on blood [ Time Frame: at baseline, 4 days, 2 weeks, and 6 months ]
    Biomarker outcome
  • Anti NMDA receptor antibody testing [ Time Frame: at 6 months ]
    Biomarker outcome
  • Proportion of patients with detectable HSV in CSF [ Time Frame: at 2 weeks ]
    Safety Outcome
  • White blood cell function [ Time Frame: at 4 days and 6 months ]
    Safety Outcome
  • Health Status Measured by the EuroQOL-5D-5Lquestionnaire [ Time Frame: at 6 and 18 months ]
  • Quality of Life measured by SF-36 questionnaires [ Time Frame: at 6 and 18 months ]


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: February 3, 2017
Date Started: June 1, 2017
Date Completion: December 1, 2020
Last Updated: March 14, 2017
Last Verified: March 2017