HSV encephalitis MedDRA version: 20.0 Level: LLT Classification code 10014590 Term: Encephalitis herpes System Organ Class: 100000013665
Conditions
Interventions
Trade Name: dexamethasone Mylan
Pharmaceutical Form: Solution for injection
Sponsors
University Hospital Grenoble
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Suspected encephalitis criteria: Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour* persisting for > 24 hours. 2. Laboratory confirmed HSV by positive PCR on CSF sample. 3. Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment 4. Age = 18 years 5. Written informed consent has been given by the patient or their legal representative Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days. 2. History of hypersensitivity to corticosteroids 3. 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 4. Pre-existing indwelling ventricular devices 5. 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 6. Currently on an antiretroviral regime containing rilpivirine 7. Subject under administrative or judicial control, person who are protected under the act. 8. Pregnant women, breastfeeding and parturient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Estimate the interest of corticoids for the improvement of the neuropsychological forecast in 6 and 18 months;Secondary Objective: •Neuropsychological and Cognitive outcome measures [at 30 days/discharge, 6 and 18 months] •Clinical Outcome •Functional Outcomes [at 30 days/discharge, 6 months and 18 months] •Imaging Outcomes [Baseline, 2 weeks, 6 months and 18 months] •Biomarker outcomes [Baseline, 4 days, 2 weeks, 6 months months] •Safety Outcomes [2 weeks] •Health Status and Quality of Life [6 months and 18 months];Primary end point(s): Verbal memory score, as determined by the Wechsler Memory Scale (WMS-IV) Auditory Memory Index ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Neuropsychological outcome measures [6 months and 18 months] - Visual, immediate and delayed memory (WMS-IV), Processing speed and working memory(WAIS-IV), Language (NAB) & Higher executive function (Trail Making Tests Past A and B) - Anxiety and Depression (BDI & BAI) - Premorbid cognitive ability (TOPF) - Subjective cognitive complaints (Perceived Deficits Questionnaire) Cognitive Outcome Measures [at 30 days/discharge, 6 and 18 months] - Addenbrooke’s Cognitive Assessment revised (ACE-III) Clinical Outcome - Incidence of epilepsy - Time to hospital discharge - Requirement of HDU/ITU admission - Time to cessation of ventilator support [if any] - Time to recovery of GCS - Survival Functional Outcomes [at 30 days/discharge, 6 months and 18 months] - Modified Rankin Score, Barthel Index, Liverpool Outcome Score and Glasgow Outcome Score Imaging Outcomes [Baseline, 2 weeks, 6 months and 18 months] - Temporal lobe volume (as % of intra-cranial volume). - Whole brain volume (as % of intra-cranial volume). - Volume of affected region as seen on FLAIR image (as % of intra-cranial volume). - Volume of affected region as seen on diffusion-weighted image (as % of intra-cranial volume). Biomarker outcomes [Baseline, 4 days, 2 weeks, 6 months months] - Transcriptomic and proteomic profiling on blood at baseline, 4 days, 2 weeks and 6 months & CSF at baseline and 2 weeks - Anti NMDA receptor antibody testing at 4 days and 6 months Safety Outcomes [2 weeks] - Proportion of patients with detectable HSV in CSF Health Status and Quality of Life [at 6 and 18 months] - Measured by the EuroQOL-5D-5L and SF-36 ;Timepoint(s) of evaluation of this end point: Baseline, J+4 days 2 weeks 30 days/discharge 6 months 18 months | — |
Countries
France
Contacts
Public ContactPr Jean-Paul STAHL
University Hospital Grenoble
Outcome results
None listed