Herpes Simplex Virus encephalitis Infections and Infestations Herpes Simplex Virus encephalitis
Conditions
Interventions
Participants are randomised to one of two groups.
Intervention group: Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Control group: Partici
Sponsors
University Of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Enrolled patients must fulfil ALL of the following criteria: 1. Suspected encephalitis criteria: New onset seizure OR, new focal neurological signs OR alteration in consciousness, cognition, personality, or behaviour* 2. A positive HSV PCR result from CSF, reported not more than 7 days prior to randomisation 3. Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose if clinically indicated 4. Age = 16 years 5. Written informed consent has been given by the patient or their legal representative * Personality / behaviour change includes: agitation, psychosis, somnolence, insomnia, catatonia, mood lability, altered sleep pattern.
Exclusion criteria
Exclusion criteria: 1. Having received oral or injectable corticosteroid therapy in the 30 days prior to the day of admission to hospital** 2. History of hypersensitivity to corticosteroids 3. Immunosuppression secondary to: 3.1. Known HIV infection AND CD4 count under 200cell/mm3 3.2. Currently taking biologic therapy or other immunosuppressive agents [azathioprine, methotrexate, ciclosporin] 3.3. Previous solid organ transplant and currently on immunosuppression 3.4. Previous bone marrow transplant 3.5. Currently undergoing a course of chemotherapy or radiotherapy 3.6. Known primary immunodeficiency syndrome 3.7. Known current haematological malignancy 4. Pre-existing indwelling ventricular devices 5. Peptic ulcer disease in the last 6 months: defined as a peptic ulcer seen at endoscopy or an upper gastrointestinal bleed causing = 2 unit haemoglobin drop in the last 6 months 6. Antiretroviral regime containing rilpivirine as current treatment **Participants are not excluded if steroids are administered after admission prior to randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verbal memory score, as determined by the Wechsler Memory Scale (WMS-IV) Auditory Memory Index at 26 weeks after randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Neuropsychological outcome measures (measured at 26 weeks and 78 weeks): 1.1. Visual Memory Index, Immediate Memory Index, and Delayed Memory Index - assessed by the Wechsler Memory Scale version IV (WMS-IV) 1.2. Processing speed and Working Memory - assessed by the Wechsler Adult Intelligence Scale version IV (WAIS-IV) 1.3. Language -assessed by the confrontational naming task of the Language Module in the Neuropsychology Assessment Battery (NAB) 1.4. Higher executive function -assessed by Trail Making Test Parts A and B 1.5. Anxiety and depression -assessed by self-completed Beck Depression Inventory and Beck Anxiety Inventory 1.6. Participant’s subjective cognitive complaints- assessed by the Perceived Deficits Questionnaire 2. Cognitive outcomes are measured using the Addenbrooke’s Cognitive Assessment (ACE-III) at 30 days/discharge, 26 weeks and 78 weeks) 3. Clinical Outcomes (measured at 30 days, 26 weeks, 78 weeks): 3.1. Incidence of epilepsy 3.2. Time to hospital discharge 3.3. Requirement of HDU/ITU admission up to 30 days post randomisation 3.4. Time to reach 14 days without ventilatory support [if any] 3.5. Time to reach maximum recorded GCS 3.6. Survival 4. Disability & Functional Outcomes are measured at 30 days/discharge, 26 weeks and 78 weeks using the Glasgow Outcome Score Extended (GOS-E), Liverpool Outcome Score (LOS), Barthel Index and the Modified Rankin Scale (mRS) 5. Imaging Outcomes (measured at baseline, 2 weeks, 26 weeks and 78 weeks): 5.1. Temporal lobe volume (as % of intra-cranial volume) 5.2. Whole brain volume (as % of intra-cranial volume) 5.3. Volume of affected region as seen on FLAIR image (as % of intra-cranial volume) | — |
Countries
United Kingdom
Contacts
Public ContactKelly Davies
Outcome results
None listed