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| Name | Class |
|---|---|
| University of Liverpool | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days. |
|
| Control group | No Intervention | Participants receive standard care and no dexamethasone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Memory Index assessed by the Wechsler Memory Scale | Neuropsychological outcome | 6 months and 18 months post randomization |
| Processing Working Memory - assessed by the Wechsler Adult Intelligence Scale version IV |
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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.
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Paul STAHL, MD | Contact | 04 76 76 68 13 | jpstahl@chu-grenoble.fr | |
| Saber TOUATI, PhD | Contact | stouati1@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul STAHL | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Gui de Chauliac | Recruiting | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16675036 | Background | 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. | |
| 20952256 | Background | 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. |
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| ID | Term |
|---|---|
| D020803 | Encephalitis, Herpes Simplex |
| ID | Term |
|---|---|
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Neuropsychological outcome
| 6 months and 18 months post randomization |
| Higher executive function -assessed by Trail Making Test Parts A and B | Neuropsychological outcome | 6 months and 18 months post randomization |
| Anxiety -assessed by self-completed Beck Anxiety Inventory | Neuropsychological outcome | 6 months and 18 months post randomization |
| Depression -assessed by self-completed Beck Depression Inventory Inventory | Neuropsychological outcome | 6 months and 18 months post randomization |
| Cognitive Assessment assessed by Addenbrooke's Cognitive Assessment revised (ACE-III) | at 30 days/discharge, 6 and 18 months |
| Requirement of intensive care or high dependency admission | clinical outcome | during 18 months |
| Time to recovery of Glasgow Coma Scale (GCS) | clinical outcome | during 18 months |
| Incidence of epilepsy | clinical outcome | during 18 months |
| Measurement of temporal lobe volume (as % of intra-cranial volume) | Imaging Outcomes | Baseline, 2 weeks, 6 months and 18 months |
| Measurement of Whole brain volume (as % of intra-cranial volume) | Imaging Outcomes | Baseline, 2 weeks, 6 months and 18 months |
| Transcriptomic and proteomic profiling on CSF | Biomarker outcomes | at baseline and 2 weeks |
| Transcriptomic and proteomic profiling on blood | Biomarker outcome | at baseline, 4 days, 2 weeks, and 6 months |
| Anti NMDA receptor antibody testing | Biomarker outcome | at 6 months |
| Proportion of patients with detectable HSV in CSF | Safety Outcome | at 2 weeks |
| Health Status Measured by the EuroQOL-5D-5L questionnaire | at 6 and 18 months |
| Quality of Life measured by SF-36 questionnaires | at 6 and 18 months |
| CHU Hôtel-Dieu | Recruiting | Nantes | 44093 | France |
|
| Hôpital Bichat-Claude Bernard, APHP | Recruiting | Paris | 75877 | France |
|
| CHU Rennes, Hôpital Pontchaillou | Recruiting | Rennes | 35000 | France |
|
| Hôpital Charles Nicolle | Recruiting | Rouen | 76031 | France |
|
| Hôpital Delafontaine | Recruiting | Saint-Denis | 93205 | France |
|
| CHU Strasbourg | Recruiting | Strasbourg | 67091 | France |
|
| CHRU de Nancy, Hopitaux de Brabois | Recruiting | Vandœuvre-lès-Nancy | 54511 | France |
|
| 18582201 | Background | 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. |
| D000069544 | Infectious Encephalitis |
| D014777 | Virus Diseases |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |