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Dexamethasone in Herpes Simplex Virus Encephalitis Open label Randomized Controlled Trial with an Observer-blinded evaluation at 6 months
EU CTIS ID: 2024-515985-16-00
What this study is testing
Estimate the interest of corticoids for the improvement of the neuropsychological forecast in 6 months
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Suspected encephalitis criteria: Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour* persisting for > 24 hours
- Laboratory confirmed HSV by positive PCR on CSF sample
- Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment
- Age ≥ 18 years
- Person affiliated to social security
- Written informed consent has been given by the patient or their legal representative
You likely can't join if
- Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days
- Any other infectious pathology in acute phase
- Subject in exclusion period of another study
- History of hypersensitivity to corticosteroids
- 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
- Pre-existing indwelling ventricular devices
See the full eligibility criteria
- Suspected encephalitis criteria: Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour* persisting for > 24 hours
- Laboratory confirmed HSV by positive PCR on CSF sample
- Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment
- Age ≥ 18 years
- Person affiliated to social security
- Written informed consent has been given by the patient or their legal representative
- Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days
- Any other infectious pathology in acute phase
- Subject in exclusion period of another study
- History of hypersensitivity to corticosteroids
- 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
- Pre-existing indwelling ventricular devices
- 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
- Currently on an antiretroviral regime containing rilpivirine
- Subject under administrative or judicial control, person who are protected under the act
- Pregnant women, breastfeeding and parturient
- Active tuberculosis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.