DexEnceph 1.0
Research type
Research Study
Full title
DexEnceph: A pragmatic, randomised, controlled, observer-blind trial comparing clinical outcomes in adults who receive dexamethasone alongside standard treatment versus standard treatment alone for Herpes Simplex Virus encephalitis.
IRAS ID
156861
Contact name
Tom Solomon
Contact email
Eudract number
2015-001609-16
Duration of Study in the UK
5 years, 8 months, 28 days
Research summary
Does dexamethasone improve outcomes in adults with HSV Encephalitis? DexEnceph, a Randomised Controlled Study.
Encephalitis means inflammation (swelling) of the brain and in the UK is most often caused by a virus, the Herpes Simplex Virus (HSV).
HSV encephalitis is a devastating illness. It affects 1 per 250-500,000 people in the UK each year and is classed as a “very rare” disease. Its impact is disproportionately large: 1 in 10 people die, survivors can be left with memory loss, this has huge socioeconomic demands on patients, carers and health services. Verbal memory is especially affected in survivors, this is the ability to remember names of objects and people, and to listen and remember spoken information.
Inflammation occurs as part of the body’s response to the infection and, in the fixed space of the skull, can lead to damage. Dexamethasone is a steroid drug that decreases inflammation.
DexEnceph is a trial that aims to find if dexamethasone benefits people with HSV encephalitis.
DexEnceph will recruit 90 adults (age≥16) with confirmed HSV encephalitis across UK hospitals over 4 years. Half of the participants will receive dexamethasone and half will not. Those that receive the study drug will receive 10mg of dexamethasone, 4 times a day, for 4 days.
All 90 patients will undergo the same assessments over 18 months.
DexEnceph’s main aim is to find if dexamethasone improves verbal memory 6 months after the infection, this is done through neuropsychology testing.
Participants will also have MRI scans, blood and cerebrospinal fluid (CSF, the fluid around the brain and spinal cord) tests, and assessments of disability and quality of life.We will also collect data from a further 90 participants with symptoms of HSV encephalitis but that go on to have other conditions. This aims to understand the differences in the body’s response in people with symptoms of encephalitis.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0545
Date of REC Opinion
10 Aug 2015
REC opinion
Further Information Favourable Opinion