Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2018-11-01
2020-12-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Dexamethasone
Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Control group
Participants receive standard care and no dexamethasone.
No interventions assigned to this group
Interventions
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Dexamethasone
Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Liverpool
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean-Paul STAHL
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Hôpital Gui de Chauliac
Montpellier, , France
CHU Hôtel-Dieu
Nantes, , France
Hôpital Bichat-Claude Bernard, APHP
Paris, , France
CHU Rennes, Hôpital Pontchaillou
Rennes, , France
Hôpital Charles Nicolle
Rouen, , France
Hôpital Delafontaine
Saint-Denis, , France
CHU Strasbourg
Strasbourg, , France
CHRU de Nancy, Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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References
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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.
Granerod 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.
Tunkel 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.
Other Identifiers
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38RC16.015
Identifier Type: -
Identifier Source: org_study_id
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