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Dexamethasone in Herpes Simplex Virus Encephalitis Open label Randomized Controlled Trial with an Observer-blinded evaluation at 6 months

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515985-16-00
Acronym
38RC16.015
Enrollment
35
Registered
2024-09-13
Start date
2019-04-25
Completion date
2025-05-07
Last updated
2024-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex Virus Encephalitis

Brief summary

Verbal memory score, as determined by the Wechsler Memory Scale (WMS-IV) Auditory Memory Index at 6 months, single blind evaluation

Detailed description

Neuropsychological outcome measures [6 months and 18 months]: - Visual, immediate and delayed memory (WMS-IV), Processing speed and working memory(WAIS-IV), & Higher executive function (Trail Making Tests Past A and B) - Anxiety and Depression (BDI & BAI), 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, 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 2 weeks and 6 months if necessary), 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

Interventions

DRUGDexamethasone 20mg/5ml Oral Solution

Sponsors

Centre Hospitalier Universitaire Grenoble Alpes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Verbal memory score, as determined by the Wechsler Memory Scale (WMS-IV) Auditory Memory Index at 6 months, single blind evaluation

Secondary

MeasureTime frame
Neuropsychological outcome measures [6 months and 18 months]: - Visual, immediate and delayed memory (WMS-IV), Processing speed and working memory(WAIS-IV), & Higher executive function (Trail Making Tests Past A and B) - Anxiety and Depression (BDI & BAI), 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, 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 2 weeks and 6 month

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026