Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

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

This research is investigating if a steroid medicine, dexamethasone, can help people with brain inflammation caused by the herpes simplex virus. The main goal is to see if taking dexamethasone improves verbal memory six months after the treatment in adults. Researchers will also look at other things like visual memory, thinking speed, mood, and how well people can do daily activities. They are also checking how safe the treatment is and how it affects overall health and quality of life. This study is for adults over 18, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Enrolment target

Start

13 Sep 2024

Herpes Simplex Virus Encephalitis

What is this study about?

Imagine your brain gets a serious infection from the herpes simplex virus, a bit like the cold sore virus, but in your brain. This can cause inflammation, which doctors call encephalitis. This condition can lead to problems with memory and other brain functions.

Doctors are always looking for better ways to help people recover from serious illnesses like this. This particular study wants to find out if a common medicine called dexamethasone, which is a type of steroid, can help people who have herpes simplex virus encephalitis. Steroids can reduce swelling and inflammation in the body, and the hope is that by reducing brain swelling, it might help protect the brain and improve recovery, especially memory.

The main thing the doctors want to measure is how well people remember things, particularly verbal memory, six months after they start treatment. They will use special tests to check this. They will also look at many other aspects of recovery, like other types of memory, how quickly people can think, their mood, and their general ability to perform daily tasks. Safety is also very important, and they will carefully monitor for any side effects.

Key takeaways

The study is investigating if dexamethasone helps adults with herpes simplex virus encephalitis.
It particularly focuses on improving memory after this brain infection.
Participants will take dexamethasone by mouth.
There will be checks on memory, thinking skills, mood, and daily activities over 18 months.
Both men and women, aged 18 and over, can participate.
Safety is carefully monitored throughout the study.

Who may be eligible?

This study is looking for adults who have been diagnosed with herpes simplex virus encephalitis. This means you must have this specific type of brain infection to be considered for the study.

To join, you need to be 18 years old or older. There is no upper age limit, so people of all adult ages can take part. Both men and women are welcome to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older.
I have been diagnosed with herpes simplex virus encephalitis.
My doctors think I might be suitable for this type of research.
I am able to provide informed consent (or have someone to do so for me if needed).

Answer every question to see your result.

What does participation involve?

If you take part in this study, you'll be given the medication dexamethasone as a liquid solution that you drink, along with the usual treatment you would receive for your condition. The study compares this new approach to standard care. Your health will be carefully watched by doctors and nurses.

Throughout the study, you'll have several assessments. These will involve tests to check your memory and thinking skills, likely at 30 days (or when you leave the hospital), then again at 6 months and 18 months. You'll also complete questionnaires about your mood, daily activities, and general health and quality of life at these later time points. There will also be blood and possibly spinal fluid (CSF) tests at different stages – at the start, after 4 days, then at 2 weeks, and again at 6 months.

The total duration of your involvement in the study, including follow-up, will be 18 months from when you start the treatment.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. For this study, the potential benefit is that dexamethasone might help improve your recovery, particularly your memory, after herpes simplex virus encephalitis. However, there's no guarantee, and like all medications, dexamethasone can have side effects. These will be carefully explained to you by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is herpes simplex virus encephalitis?

It's a serious and rare infection where the herpes simplex virus causes inflammation in your brain cells.

What is dexamethasone?

It's a type of steroid medicine that's often used to reduce swelling and inflammation in the body.

Why is memory important in this study?

Herpes simplex virus encephalitis can affect memory, so the study wants to see if the treatment helps improve it.

How long will the study last for me?

Your participation will involve follow-up for 18 months from the time you start the treatment.

Will I know if I'm getting dexamethasone?

Yes, in this study, it's 'open-label,' meaning both you and your doctor will know if you're receiving dexamethasone.