Does dexamethasone improve outcomes in adults with HSV encephalitis?

Phase 3

• Conditions: Herpes Simplex Virus encephalitis; Infections and Infestations

• Registration Number: ISRCTN11774734
• Lead Sponsor: niversity Of Liverpool

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34301646/ protocol (added 26/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-31
• Last Update Posted: 10 August 2021
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 180

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified