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Protocol for DexEnceph: a randomised controlled trial of dexamethasone therapy in adults with herpes simplex virus encephalitis

BMJ open, 2021-07, Vol.11 (7), p.e041808-e041808 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. ;2021 Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. 2021 ;ISSN: 2044-6055 ;EISSN: 2044-6055 ;DOI: 10.1136/bmjopen-2020-041808 ;PMID: 34301646

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  • Title:
    Protocol for DexEnceph: a randomised controlled trial of dexamethasone therapy in adults with herpes simplex virus encephalitis
  • Author: Whitfield, Thomas ; Fernandez, Cristina ; Davies, Kelly ; Defres, Sylviane ; Griffiths, Michael ; Hooper, Cory ; Tangney, Rebecca ; Burnside, Girvan ; Rosala- Hallas, Anna ; Moore, Perry ; Das, Kumar ; Zuckerman, Mark ; Parkes, Laura ; Keller, Simon ; Roberts, Neil ; Easton, Ava ; Touati, Saber ; Kneen, Rachel ; Stahl, J P ; Solomon, Tom
  • Subjects: Adult ; Antiviral drugs ; Clinical trials ; COVID-19 ; Dexamethasone - therapeutic use ; Encephalitis ; Herpes viruses ; Humans ; Inflammation ; Medical imaging ; Memory ; Meningitis ; Multicenter Studies as Topic ; Neurology ; Neuropsychology ; Patients ; Personality ; Randomized Controlled Trials as Topic ; Rare diseases ; SARS-CoV-2 ; Simplexvirus ; Steroids ; Treatment Outcome ; Ulcers
  • Is Part Of: BMJ open, 2021-07, Vol.11 (7), p.e041808-e041808
  • Description: IntroductionHerpes simplex virus (HSV) encephalitis is a rare severe form of brain inflammation that commonly leaves survivors and their families with devastating long-term consequences. The virus particularly targets the temporal lobe of the brain causing debilitating problems in memory, especially verbal memory. It is postulated that immunomodulation with the corticosteroid, dexamethasone, could improve outcomes by reducing brain swelling. However, there are concerns (so far not observed) that such immunosuppression might facilitate increased viral replication with resultant worsening of disease. A previous trail closed early because of slow recruitment.MethodDexEnceph is a pragmatic multicentre, randomised, controlled, open-label, observer-blind trial to determine whether adults with HSV encephalitis who receive dexamethasone alongside standard antiviral treatment with aciclovir for have improved clinical outcomes compared with those who receive standard treatment alone. Overall, 90 patients with HSV encephalitis are being recruited from a target of 45 recruiting sites; patients are randomised 1:1 to the dexamethasone or control arms of the study. The primary outcome measured is verbal memory as assessed by the Weschler Memory Scale fourth edition Auditory Memory Index at 26 weeks after randomisation. Secondary outcomes are measured up to 72 weeks include additional neuropsychological, clinical and functional outcomes as well as comparison of neuroimaging findings. Patient safety monitoring occurs throughout and includes the detection of HSV DNA in cerebrospinal fluid 2 weeks after randomisation, which is indicative of ongoing viral replication. Innovative methods are being used to ensure recrutiment targets are met for this rare disease.DiscussionDexEnceph aims to be the first completed randomised controlled trial of corticosteroid therapy in HSV encephalitis. The results will provide evidence for future practice in managing adults with the condition and has the potential to improve outcomes .Ethics and disseminationThe trial has ethical approval from the UK National Research Ethics Committee (Liverpool Central, REF: 15/NW/0545, 10 August 2015). Protocol V.2.1, July 2019. The results will be published and presented as soon as possible on completion.Trial registration numbersISRCTN11774734, EUDRACT 2015-001609-16.
  • Publisher: England: BMJ Publishing Group LTD
  • Language: English
  • Identifier: ISSN: 2044-6055
    EISSN: 2044-6055
    DOI: 10.1136/bmjopen-2020-041808
    PMID: 34301646
  • Source: ProQuest One Psychology
    BMJ Open Access Journals
    GFMER Free Medical Journals
    MEDLINE
    PubMed Central
    Coronavirus Research Database
    ROAD: Directory of Open Access Scholarly Resources
    ProQuest Central
    DOAJ Directory of Open Access Journals
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