DexEnceph: A study of dexamethasone in adults with Herpes Simplex Virus (HSV) encephalitis
Why I have been sent a link to the DexEnceph summary results?
You have been sent a link to these summary results because the DexEnceph study has now finished, and we wanted to let you know what we found out during the study. We also wanted to thank you again for taking part in this study; the results of this study could lead to a positive change to how patients like you are being treated. The information we have collected is very important and tells us a lot. We could not have done this without your help and participation.
What was the purpose of the study?
The purpose of the study was to look at how effective the use of dexamethasone in combination with standard treatment of acyclovir is in improving the recovery of patients with (Herpes Simplex Virus) HSV encephalitis.
Why was I invited?
You were asked to participate because you were diagnosed with HSV encephalitis. A total of 94 participants aged 16 years and older with HSV encephalitis throughout the UK participated in the study.
Which drug/ drugs were being tested?
The study involved the use of dexamethasone given together with acyclovir compared to standard treatment of acyclovir alone.
Dexamethasone is used widely in patients and the side-effects are well known as this medicine has been prescribed for a long time. A short course of dexamethasone was prescribed in this study. Dexamethasone is a type of medicine called a steroid and treats health conditions such as severe allergies, skin conditions, sickness and swelling in the eye. It was also recently used as a treatment for severe COVID-19 and other serious infections.
Acyclovir was introduced in the 1980s and significantly reduced the mortality from HSV encephalitis. Despite treatment, some people are left with significant loss of memory. About 2 out of every 3 people will have memory difficulties long term.
What happens to me now the study has stopped?
After you finished taking part in the study, your doctor will have explained what happens next. Your doctor will have treated you according to normal clinical practice.
Are there any side effects that we should report now the study has ended?
During the study we closely monitored any side effects that may have been experienced by you. Now that the study has finished your doctor has been asked to report any side effects, they feel that may have been related to dexamethasone. If you are concerned at any time, please contact the doctor or nurse who looked after you during the study.
Will my taking part in the study be kept confidential?
Yes. We will follow ethical and legal practice and all information which is collected about you during the research will be kept strictly confidential. All data collected during the study will be kept for a maximum of 15 years after the study has ended, during this time all your information will be kept confidential.
What were the results of the study and how will they be made available?
In the DexEnceph study we looked at each participant after 26 weeks from taking part to see if there had been an improvement in verbal memory.
Between Sept 22, 2016, and Feb 2, 2022, 94 participants with HSV encephalitis were recruited, 47 to the treatment group (dexamethasone plus acyclovir), and 47 to the control group (acyclovir alone).
The results of the study showed that there was not a big difference in verbal memory scores between the treatment and the control group. However, the results suggest that participants starting dexamethasone treatment sooner had better verbal memory scores than those starting the treatment later; so, it may be beneficial if given early.
Dexamethasone treatment in HSV encephalitis is not harmful, the results showed that it was safe and well tolerated. Participants taking dexamethasone plus acyclovir did not show any major differences in side effects compared with participants taking acyclovir alone.
This is the first ever completed study of dexamethasone in HSV encephalitis in the world, with 94 participants from 39 UK hospitals taking part.
Have the results of the study been seen by anyone else?
Some of the results were shown at the encephalitis international conference in December 2024. This conference was attended by encephalitis experts from around the world.
Will I be given any results about me as an individual?
We will not publish any individual results, if you would like to know more about your results during the study please speak to your study nurse or doctor.
Invitation to take part in patient involvement
When research studies like this one are being set up, we like to get input from patients into the design of the study and what impact the study may have on patients. We also like to have patient involvement throughout the study.
Examples of patient involvement include:
- help make sure researchers ask the right questions
- help make sure the research design is appropriate
- help make sure information about the research is easy to understand
- help make sure reported results are clear and easy to understand
If this is something you might be interested in doing, please visit the following websites which provide general information about patient and public involvement in research including how you can get involved:
The National Institute for Health Research website
The Liverpool Clinical Trials Centre, University of Liverpool is keen to ensure patients, and the public could be actively involved in research.
Contact details
Please contact your doctor or nurse on the telephone number you were given when you joined the study if you have any queries.
Thank you
We want to thank you again for taking part in this study. The results of this study could make a positive change to how other patients like you are being treated. We could not have done this groundbreaking study without the help and participation of the patients and families that took part in the study.
This study has been funded by the National Institute for Health Research's Efficacy and Mechanism Evaluation (EME) Programme (ref: 12/205/28)..
The University Of Liverpool.
The study has been reviewed by a research ethics committee, who have agreed the study is being conducted in a correct and appropriate manner. The study has also been approved by the Medicines & Healthcare products Regulatory Agency (MHRA).
HSV encephalitis ?
Encephalitis means swelling of the brain and has many different causes. It is often caused by a virus. Herpes Simplex Virus (HSV) is the most common virus that causes encephalitis in the UK.
HSV encephalitis is very rare. It is diagnosed by finding the virus in fluid around the brain and spinal cord. This fluid is called CSF (cerebrospinal fluid). The CSF is obtained by the doctor who performs a lumbar puncture (LP).
HSV encephalitis is treated with the drug aciclovir. Despite treatment, some people are left with significant loss of memory. About 2 out of every 3 people will have memory difficulties long term.
Why are we doing this study?
We know dexamethasone can reduce swelling. Reduction in swelling of the brain may improve the recovery of patients with HSV encephalitis.
This study, called DexEnceph, will allow us to compare the recovery of patients that received dexamethasone and those that did not.
Why me?
There are two reasons why you may have been invited to take part:
Do I have to say yes?
No not at all. It’s completely up to you. We only want you to take part if you want to. Just tell us if you don’t.
If you decide not to, don’t worry, it won’t change how you are looked after.
If you decide to take part, you will be given this leaflet to keep. You will be asked if you would like to sign a form to say that you understand what will happen and that you are happy to take part. Your parent/carer(s) will also have to sign a form to say they are happy for you to take part.
If you decide to take part that would be really helpful. If you then change your mind, that’s OK as well - you can, and don’t have to say why if you don’t want to.
What will happen to me during the study?
All patients in the study will receive aciclovir. This is standard treatment for HSV encephalitis.
In addition, if you decide to take part in the study, you may be offered a short course of dexamethasone. This will be decided at random by a computer. This is to be fair, so neither you, your doctor, nor the research team, can choose whether you receive dexamethasone or not. Half of the people in the study will receive dexamethasone and half will not.
If you receive dexamethasone this will be 4 times a day for 4 days. It is given in a line you already have for clinical care.
Please feel free to contact the DexEnceph study team by any of the means below: