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Dexamethasone in Herpes Simplex Virus Encephalitis (DexEnceph)

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ClinicalTrials.gov Identifier: NCT03084783
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : September 4, 2020
Sponsor:
Collaborator:
University of Liverpool
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE March 21, 2017
Last Update Posted Date September 4, 2020
Actual Study Start Date  ICMJE November 1, 2018
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2018)
  • 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
  • Higher executive function -assessed by Trail Making Test Parts A and B [ 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
  • 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
  • Health Status Measured by the EuroQOL-5D-5L questionnaire [ 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 Measures  ICMJE
 (submitted: March 14, 2017)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone in Herpes Simplex Virus Encephalitis
Official Title  ICMJE Dexamethasone in Herpes Simplex Virus Encephalitis Open Label Randomized Controlled Trial With an Observer-blinded Evaluation at 6 Months
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE HSV Encephalitis
Intervention  ICMJE Drug: Dexamethasone
Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Study Arms  ICMJE
  • Experimental: Intervention group
    Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
    Intervention: Drug: Dexamethasone
  • No Intervention: Control group
    Participants receive standard care and no dexamethasone.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2020
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jean-Paul STAHL, MD 04 76 76 68 13 jpstahl@chu-grenoble.fr
Contact: Saber TOUATI, PhD stouati1@chu-grenoble.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03084783
Other Study ID Numbers  ICMJE 38RC16.015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE University of Liverpool
Investigators  ICMJE
Principal Investigator: Jean-Paul STAHL University Hospital, Grenoble
PRS Account University Hospital, Grenoble
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP