Dexamethasone in Herpes Simplex Virus Encephalitis
DexEnceph
1 other identifier
interventional
30
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2018
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedSeptember 4, 2020
September 1, 2020
2 years
February 3, 2017
September 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calcul of verbal memory score
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.
at 6 months post randomization
Secondary Outcomes (17)
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
Higher executive function -assessed by Trail Making Test Parts A and B
6 months and 18 months post randomization
Anxiety -assessed by self-completed Beck Anxiety Inventory
6 months and 18 months post randomization
Depression -assessed by self-completed Beck Depression Inventory Inventory
6 months and 18 months post randomization
- +12 more secondary outcomes
Study Arms (2)
Intervention group
EXPERIMENTALParticipants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Control group
NO INTERVENTIONParticipants receive standard care and no dexamethasone.
Interventions
Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Grenoblelead
- University of Liverpoolcollaborator
Study Sites (8)
Hôpital Gui de Chauliac
Montpellier, 34295, France
CHU Hôtel-Dieu
Nantes, 44093, France
Hôpital Bichat-Claude Bernard, APHP
Paris, 75877, France
CHU Rennes, Hôpital Pontchaillou
Rennes, 35000, France
Hôpital Charles Nicolle
Rouen, 76031, France
Hôpital Delafontaine
Saint-Denis, 93205, France
CHU Strasbourg
Strasbourg, 67091, France
CHRU de Nancy, Hopitaux de Brabois
Vandœuvre-lès-Nancy, 54511, France
Related Publications (3)
Whitley RJ. Herpes simplex encephalitis: adolescents and adults. Antiviral Res. 2006 Sep;71(2-3):141-8. doi: 10.1016/j.antiviral.2006.04.002. Epub 2006 Apr 25.
PMID: 16675036BACKGROUNDGranerod J, Ambrose HE, Davies NW, Clewley JP, Walsh AL, Morgan D, Cunningham R, Zuckerman M, Mutton KJ, Solomon T, Ward KN, Lunn MP, Irani SR, Vincent A, Brown DW, Crowcroft NS; UK Health Protection Agency (HPA) Aetiology of Encephalitis Study Group. Causes of encephalitis and differences in their clinical presentations in England: a multicentre, population-based prospective study. Lancet Infect Dis. 2010 Dec;10(12):835-44. doi: 10.1016/S1473-3099(10)70222-X. Epub 2010 Oct 15.
PMID: 20952256BACKGROUNDTunkel AR, Glaser CA, Bloch KC, Sejvar JJ, Marra CM, Roos KL, Hartman BJ, Kaplan SL, Scheld WM, Whitley RJ; Infectious Diseases Society of America. The management of encephalitis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2008 Aug 1;47(3):303-27. doi: 10.1086/589747.
PMID: 18582201BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Paul STAHL
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2017
First Posted
March 21, 2017
Study Start
November 1, 2018
Primary Completion
November 1, 2020
Study Completion
December 1, 2020
Last Updated
September 4, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share