Overview

DexEnceph: A study of dexamethasone in adults with Herpes Simplex Virus (HSV) encephalitis

HSV Hotline: 0300 008 0007        E-Mail:  dexenceph@liverpool.ac.uk
  • This is a study for patients with encephalitis (swelling of the brain) caused by a virus called herpes simplex virus (HSV).
  • Encephalitis can make you confused, drowsy, behave out of character, affect your sleep and memory, change your mood, cause you to have fits and often leaves patients with memory problems.
  • We want to find out if reducing the swelling with a drug called dexamethasone is of benefit to patient’s memory in the longer term.
  • Dexamethasone is a commonly used drug in brain swelling and many other conditions
  • In the study there will be two groups of patients, one that receives dexamethasone for 4 days and one that does not.
  • Both groups will have the same investigations to see if dexamethasone has been of benefit.
  • The study is being run through Brain Infections UK from the Institute of Infection and Global Health in collaboration with the Encephalitis society and Walton Centre.

Randomised patients

7

Target patients

90

Open sites

27

Target Sites

90

Collaborators

The University of Liverpool    The Clinical Trials Research Center    The UK Clinical Virology Network    The University of Manchester    The Encephalitis Society    The Walton Centre

Study funder

This study has been funded by the National Institute for Health Research's Efficacy and Mechanism Evaluation (EME) Programme (ref: 12/205/28)..

Study Sponsor

The University Of Liverpool.

Study review and approval

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).

Trial Summary and Frequently Asked Questions

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:

  • Your doctors have diagnosed you with having HSV encephalitis.
or
  • You may have been invited to take part before the diagnosis is made. This is because your doctors think there is a chance you may have HSV encephalitis. This will mean you have more time to think about taking 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.

Recruiting Centres

Contacts

Please feel free to contact the DexEnceph study team by any of the means below:

Telephone


0151 794 9767

HSV Hotline: 030 0008 0007

Address

Medicines for Children Clinical Trials Unit
University of Liverpool
Institute of Child Health
Alder Hey Children's NHS Foundation Trust
Liverpool
L12 2AP