German Trial of Acyclovir and Corticosteroids in Herpes-simplex-virus-encephalitis (HSVE); a multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial.
- Conditions
- encephalitis10007951
- Registration Number
- NL-OMON30943
- Lead Sponsor
- niversiteit van Heidelberg, afdeling Neurologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Patients with proven HSVE (positive HSV-DNA-PCR); age 18-85 years; focal neurological signs not longer than 5 days prior to admission; informed consent; woman of childbearing potential: negative pregnancy testing in urine.
Exclusion Criteria
History of hypersensitivity to corticosteroids; systemic corticosteroid treatment within the last 6 months or at present time; two fixed dilated pupils; pre-event score mRS>2; pregnancy; breast feeding woman; recent history of active tuberculosis or systemic fungal infection; recent head trauma/neurosurgery/peptic ulcer disease; life expectancy < 3 years; participation in another clinical trial; acute viral infections other than HSVE.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>A binary functional outcome 6 months (± 14 days) after randomization (measured<br /><br>by the modified Rankin scale, a seven-point-scale 0-6). A mRS of 3 to 6 will be<br /><br>seen as an unfavourable outcome (=failure). Patients dying between<br /><br>randomization and 6 months follow-up will be evaluated with mRS=6.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br>1. Mortality at 6 months after randomization.<br /><br>2. Mortality at 12 months after randomization.<br /><br>3. Functional outcome (Glasgow outcome scale: GOS) and quality of life (EuroQol<br /><br>5D)<br /><br>6 months (± 14 days) after randomization.<br /><br>4. Functional outcome (mRS, GOS) and quality of life (EuroQol 5D) 12 months (±<br /><br>28<br /><br>days) after randomization.<br /><br>5. Neuropsychological testing 6 months (± 14 days) after randomization.<br /><br>6. MRI at 6 months (± 14 days) after randomization.<br /><br>7. Seizures up to discharge (or at the latest at day 30), 6 months and 12<br /><br>months after randomization.</p><br>