Dexamethasone in Herpes Simplex Virus Encephalitis

NCT ID: NCT03084783

Last Updated: 2020-09-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-12-01

Brief Summary

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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

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Conditions

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HSV Encephalitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.

Control group

Participants receive standard care and no dexamethasone.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dexamethasone

Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liverpool

OTHER

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

CHU Hôtel-Dieu

Nantes, , France

Site Status RECRUITING

Hôpital Bichat-Claude Bernard, APHP

Paris, , France

Site Status RECRUITING

CHU Rennes, Hôpital Pontchaillou

Rennes, , France

Site Status RECRUITING

Hôpital Charles Nicolle

Rouen, , France

Site Status RECRUITING

Hôpital Delafontaine

Saint-Denis, , France

Site Status RECRUITING

CHU Strasbourg

Strasbourg, , France

Site Status RECRUITING

CHRU de Nancy, Hopitaux de Brabois

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Paul STAHL, MD

Role: CONTACT

04 76 76 68 13

Saber TOUATI, PhD

Role: CONTACT

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.

Reference Type BACKGROUND
PMID: 16675036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20952256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18582201 (View on PubMed)

Other Identifiers

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38RC16.015

Identifier Type: -

Identifier Source: org_study_id

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