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Study on Dexamethasone for Patients with Herpes Simplex Virus Encephalitis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Herpes Simplex Virus Encephalitis, a serious brain infection caused by the herpes simplex virus. The study is investigating the use of Dexamethasone, a medication that is given as an oral solution, to see if it can help improve brain function and recovery in patients affected by this condition. The purpose of the study is to determine if using this medication can lead to better outcomes in terms of memory and overall brain health six months after treatment.

Participants in the study will receive either Dexamethasone or a placebo, in addition to the standard treatment for the infection. The study will follow patients over a period of time to assess their recovery and brain function. This includes checking memory, processing speed, and other cognitive abilities at different intervals, such as six months and eighteen months after starting the treatment. The study will also look at other health outcomes, like the occurrence of seizures, time spent in the hospital, and overall survival.

Throughout the study, various tests will be conducted to monitor the patients' progress. These tests will include assessments of memory and cognitive function, as well as evaluations of anxiety and depression. Additionally, the study will measure the quality of life and health status of participants at different points in time. The goal is to gather comprehensive information on how Dexamethasone affects recovery from Herpes Simplex Virus Encephalitis and to determine if it can be a beneficial addition to the current treatment options.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting specific criteria, including a confirmed diagnosis of Herpes Simplex Virus Encephalitis and providing written consent.

    Eligibility requires being 18 years or older and having a laboratory-confirmed infection.

  2. Step 2

    Initial treatment

    Receive intravenous aciclovir at a dose of 10 mg per kg three times a day, adjusted for kidney function if necessary.

    This medication is used to treat the viral infection.

  3. Step 3

    Administration of dexamethasone

    Receive Dexamethasone 20mg/5ml Oral Solution as part of the study treatment.

    This medication is administered to evaluate its effect on long-term brain function recovery.

  4. Step 4

    Evaluation of memory and cognitive function

    Memory and cognitive abilities are assessed using the Wechsler Memory Scale and other tests at 6 months.

    These evaluations help determine the impact of the treatment on brain function.

  5. Step 5

    Monitoring and follow-up

    Regular assessments occur at 30 days, 6 months, and 18 months to monitor recovery and any side effects.

    These include tests for memory, cognitive function, and overall health status.

  6. Step 6

    Safety and health status checks

    Safety is monitored by checking for the presence of the virus in the spinal fluid and other health indicators.

    Quality of life is assessed using standardized questionnaires at 6 and 18 months.

Who can join the trial?

6 criteria

  • The patient must have a suspected case of **encephalitis**, which is an inflammation of the brain. This should be acute or subacute, meaning it has developed quickly or over a few weeks, and it should cause changes in consciousness, thinking, personality, or behavior that last for more than 24 hours.
  • The patient must have a laboratory-confirmed infection with the **Herpes Simplex Virus (HSV)**, shown by a positive test called **PCR** on a sample of the fluid around the brain and spinal cord, known as **CSF**.
  • The patient must be receiving a medication called **aciclovir** through a vein, at a dose of 10 mg per kilogram of body weight three times a day, or at a lower dose if they have kidney problems.
  • The patient must be 18 years of age or older.
  • The patient must be affiliated with social security.
  • Written informed consent must be given by the patient or their legal representative, meaning they agree to participate in the study after being informed about it.

Who cannot join the trial?

2 criteria

  • Individuals who are not between the ages of 3 and 4 years old cannot participate.
  • Participants must not belong to a vulnerable population, which means they should not be in a situation where they are at a higher risk of harm or exploitation.
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Investigated drugs

Dexamethasone is a medication used in this trial to see if it can help improve brain function and recovery in patients with Herpes Simplex Virus Encephalitis. It is a type of corticosteroid that reduces inflammation and is being tested to determine if it can improve long-term outcomes for patients.

What is already known about the treatment

Dexamethasone – Dexamethasone is administered orally or intravenously, depending on the specific medical condition being treated. It is currently being studied in clinical trials for its potential benefits in treating Herpes Simplex Virus Encephalitis. The main therapeutic indication for dexamethasone in this context is to improve neuropsychological outcomes in patients. At the molecular level, dexamethasone works by suppressing inflammation and modulating the immune response, which can help reduce swelling and pressure in the brain. It is classified as a corticosteroid, a type of medication that mimics the effects of hormones produced by the adrenal glands.

Investigated diseases

Herpes Simplex Virus Encephalitis – This disease is an inflammation of the brain caused by the herpes simplex virus. It typically begins with symptoms such as fever, headache, and confusion, which can progress to more severe neurological issues like seizures and altered consciousness. The virus primarily affects the temporal lobes of the brain, leading to problems with memory and behavior. As the condition advances, patients may experience difficulties with speech and comprehension. The progression of the disease can vary, with some individuals experiencing rapid deterioration, while others may have a more gradual onset of symptoms. Early intervention is crucial to manage the inflammation and prevent further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515985-16-00Protocol code38RC16.015Estimated enrolment35 patientsSponsorCentre Hospitalier Universitaire Grenoble Alpes

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