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Trial record 1 of 1 for:    "Herpes Simplex Encephalitis" | "Autonomic Agents"
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Dexamethasone in Herpes Simplex Virus Encephalitis (DexEnceph)

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ClinicalTrials.gov Identifier: NCT03084783
Recruitment Status : Not yet recruiting
First Posted : March 21, 2017
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
University of Liverpool
Information provided by (Responsible Party):
University Hospital, Grenoble

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.


Condition or disease Intervention/treatment Phase
HSV Encephalitis Drug: Dexamethasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone in Herpes Simplex Virus Encephalitis Open Label Randomized Controlled Trial With an Observer-blinded Evaluation at 6 Months
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2020


Arm Intervention/treatment
Experimental: Intervention group
Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Drug: Dexamethasone
Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.

No Intervention: Control group
Participants receive standard care and no dexamethasone.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Visual Memory Index assessed by the Wechsler Memory Scale [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome

  2. Processing Working Memory - assessed by the Wechsler Adult Intelligence Scale version IV [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome

  3. Higher executive function -assessed by Trail Making Test Parts A and B [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome

  4. Anxiety -assessed by self-completed Beck Anxiety Inventory [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome

  5. Depression -assessed by self-completed Beck Depression Inventory Inventory [ Time Frame: 6 months and 18 months post randomization ]
    Neuropsychological outcome

  6. Cognitive Assessment assessed by Addenbrooke's Cognitive Assessment revised (ACE-III) [ Time Frame: at 30 days/discharge, 6 and 18 months ]
  7. Requirement of intensive care or high dependency admission [ Time Frame: during 18 months ]
    clinical outcome

  8. Time to recovery of Glasgow Coma Scale (GCS) [ Time Frame: during 18 months ]
    clinical outcome

  9. Incidence of epilepsy [ Time Frame: during 18 months ]
    clinical outcome

  10. Measurement of temporal lobe volume (as % of intra-cranial volume) [ Time Frame: Baseline, 2 weeks, 6 months and 18 months ]
    Imaging Outcomes

  11. Measurement of Whole brain volume (as % of intra-cranial volume) [ Time Frame: Baseline, 2 weeks, 6 months and 18 months ]
    Imaging Outcomes

  12. Transcriptomic and proteomic profiling on CSF [ Time Frame: at baseline and 2 weeks ]
    Biomarker outcomes

  13. Transcriptomic and proteomic profiling on blood [ Time Frame: at baseline, 4 days, 2 weeks, and 6 months ]
    Biomarker outcome

  14. Anti NMDA receptor antibody testing [ Time Frame: at 6 months ]
    Biomarker outcome

  15. Proportion of patients with detectable HSV in CSF [ Time Frame: at 2 weeks ]
    Safety Outcome

  16. Health Status Measured by the EuroQOL-5D-5L questionnaire [ Time Frame: at 6 and 18 months ]
  17. Quality of Life measured by SF-36 questionnaires [ Time Frame: at 6 and 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084783


Contacts
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Contact: Jean-Paul STAHL 04 76 76 68 13 jpstahl@chu-grenoble.fr
Contact: Anaïs ADOLLE aadolle@chu-grenoble.fr

Locations
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France
Hôpital Gui de Chauliac
Montpellier, France, 34295
CHU Hôtel-Dieu
Nantes, France, 44093
Hôpital Bichat-Claude Bernard, APHP
Paris, France, 75877
CHU Rennes, Hôpital Pontchaillou
Rennes, France, 35000
Hôpital Charles Nicolle
Rouen, France, 76031
Hôpital Delafontaine
Saint-Denis, France, 93205
CHU Strasbourg
Strasbourg, France, 67091
CHRU de Nancy, Hopitaux de Brabois
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
University Hospital, Grenoble
University of Liverpool
Investigators
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Principal Investigator: Jean-Paul STAHL University Hospital, Grenoble

Publications:
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03084783     History of Changes
Other Study ID Numbers: 38RC16.015
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Grenoble:
dexamethasone
HSV encephalitis

Additional relevant MeSH terms:
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Autonomic Agents
Herpes Simplex
Encephalitis, Herpes Simplex
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
Infectious Encephalitis
Central Nervous System Infections
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents