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HSV EncephalitisPhase 3DexEncephNCT03084783

Dexamethasone in Herpes Simplex Virus Encephalitis

A Phase 3 study testing Dexamethasone in people with HSV Encephalitis, run by University Hospital, Grenoble at 8 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Encephalitics is a serious condition in which the brain becomes inflamed (swollen). It usually happens as a direct result of virus, such as herpes simplex virus (HSV). HSV encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the growth and spread of HSV in the body). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HSV Encephalitis
What is being tested?
Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
8 sitesFrance
Study dates
1 Nov 2018to 1 Dec 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Suspected encephalitis criteria: Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour* persisting for > 24 hours Laboratory confirmed HSV by positive PCR on CSF sample.
  • Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment
  • Age ≥ 18 years
  • Person affiliated to social security
  • Written informed consent has been given by the patient or their legal representative

Who cannot join

  • Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days.
  • History of hypersensitivity to corticosteroids
  • Immunosuppression secondary to:
  • Known HIV infection \& CD4 count under 200cell/mm3
  • Biologic therapy or other immunosuppressive agents [azathioprine, methotrexate, ciclosporin]
  • Solid organ transplant on immunosuppression
Show all 16Show fewer
  • Bone marrow transplant
  • Currently undergoing a course of chemotherapy or radiotherapy
  • Known immunodeficiency syndrome [other than HIV]
  • Known haematological malignancy
  • Pre-existing indwelling ventricular devices
  • Peptic ulcer disease in the last 6 months: defined as a peptic ulcer seen at previous endoscopy or an upper gastrointestinal bleed causing ≥ 2 unit haemoglobin drop
  • Currently on an antiretroviral regime containing rilpivirine
  • Patients under legal protection, administrative or judicial control
  • Pregnancy / Breast feeding and parturient
  • Subject in exclusion period of another study

Trial locations and contacts

8 sites in 1 country.

Jean-Paul STAHL, MD contact

04 76 76 68 13

jpstahl@chu-grenoble.fr

Saber TOUATI, PhD contact

stouati1@chu-grenoble.fr

8 sites in 1 country

France8 sites, 8 recruiting

  • Hôpital Gui de Chauliac

    Montpellier, 34295

    LE MOING, MD, PhD

    Recruiting

  • CHU Hôtel-Dieu

    Nantes, 44093

    BOUTOILLE

    Recruiting

  • Hôpital Bichat-Claude Bernard, APHP

    Paris, 75877

    Romain SONNEVILLE, MD, PhD

    Recruiting

  • CHU Rennes, Hôpital Pontchaillou

    Rennes, 35000

    Pierre TATTEVIN, MD, PhD

    Recruiting

  • Hôpital Charles Nicolle

    Rouen, 76031

    Isabelle GUEIT, MD, PhD

    Recruiting

  • Hôpital Delafontaine

    Saint-Denis, 93205

    DE BROUCKER, MD, PhD

    Recruiting

  • CHU Strasbourg

    Strasbourg, 67091

    Yvon RUCH, MD

    Recruiting

  • CHRU de Nancy, Hopitaux de Brabois

    Vandœuvre-lès-Nancy, 54511

    Céline PULCINI, Md, PhD

    Recruiting

Other trials in France

About this study

Official title: Dexamethasone in Herpes Simplex Virus Encephalitis Open Label Randomized Controlled Trial With an Observer-blinded Evaluation at 6 Months

Encephalitics is a serious condition in which the brain becomes inflamed (swollen). It usually happens as a direct result of virus, such as herpes simplex virus (HSV).

HSV encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the growth and spread of HSV in the body). Despite this however, around 2 out of every 3 people will have memory difficulties long term. Dexamethasone is a corticosteroid medication, which works by preventing the release of natural chemicals in the body which cause inflammation. It is possible that dexamethasone could help to reduce in swelling of the brain may improve the recovery of patients with HSV encephalitis. The aim of this study is to find out whether treatment with dexamethasone can improve long-term health outcomes in adults with HSV Encephalitis.

Being tested
Dexamethasone
Keywords
dexamethasone, HSV encephalitis
Medical subject headings
Encephalitis, Herpes Simplex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.

Study groups in NCT03084783
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
Receives: Drug: Dexamethasone
Control groupNo interventionParticipants receive standard care and no dexamethasone.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Calcul of verbal memory score

    The primary outcome is a verbal memory score as determined by the Wechsler Memory Scale (WMS-IV) Auditory Memory Index, at 6 months post randomisation.

    Measured: at 6 months post randomization

Secondary outcomes (17)

  1. Visual Memory Index assessed by the Wechsler Memory Scale

    Neuropsychological outcome

    Measured: 6 months and 18 months post randomization

  2. Processing Working Memory - assessed by the Wechsler Adult Intelligence Scale version IV

    Neuropsychological outcome

    Measured: 6 months and 18 months post randomization

  3. Higher executive function -assessed by Trail Making Test Parts A and B

    Neuropsychological outcome

    Measured: 6 months and 18 months post randomization

  4. Anxiety -assessed by self-completed Beck Anxiety Inventory

    Neuropsychological outcome

    Measured: 6 months and 18 months post randomization

  5. Depression -assessed by self-completed Beck Depression Inventory Inventory

    Neuropsychological outcome

    Measured: 6 months and 18 months post randomization

  6. Cognitive Assessment assessed by Addenbrooke's Cognitive Assessment revised (ACE-III)

    Measured: at 30 days/discharge, 6 and 18 months

  7. Requirement of intensive care or high dependency admission

    clinical outcome

    Measured: during 18 months

  8. Time to recovery of Glasgow Coma Scale (GCS)

    clinical outcome

    Measured: during 18 months

  9. Incidence of epilepsy

    clinical outcome

    Measured: during 18 months

  10. Measurement of temporal lobe volume (as % of intra-cranial volume)

    Imaging Outcomes

    Measured: Baseline, 2 weeks, 6 months and 18 months

  11. Measurement of Whole brain volume (as % of intra-cranial volume)

    Imaging Outcomes

    Measured: Baseline, 2 weeks, 6 months and 18 months

  12. Transcriptomic and proteomic profiling on CSF

    Biomarker outcomes

    Measured: at baseline and 2 weeks

  13. Transcriptomic and proteomic profiling on blood

    Biomarker outcome

    Measured: at baseline, 4 days, 2 weeks, and 6 months

  14. Anti NMDA receptor antibody testing

    Biomarker outcome

    Measured: at 6 months

  15. Proportion of patients with detectable HSV in CSF

    Safety Outcome

    Measured: at 2 weeks

  16. Health Status Measured by the EuroQOL-5D-5L questionnaire

    Measured: at 6 and 18 months

  17. Quality of Life measured by SF-36 questionnaires

    Measured: at 6 and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2017
  2. Study start1 Nov 2018
  3. Primary completion1 Nov 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03084783
Sponsor's protocol ID
38RC16.015
Acronym
DexEnceph
Status last verified
Sep 2020
First submitted
3 Feb 2017
Last updated
4 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Whitley RJ. Herpes simplex encephalitis: adolescents and adults. Antiviral Res. 2006 Sep;71(2-3):141-8. doi: 10.1016/j.antiviral.2006.04.002. Epub 2006 Apr 25.

    PubMed 16675036

  • Granerod J, Ambrose HE, Davies NW, Clewley JP, Walsh AL, Morgan D, Cunningham R, Zuckerman M, Mutton KJ, Solomon T, Ward KN, Lunn MP, Irani SR, Vincent A, Brown DW, Crowcroft NS; UK Health Protection Agency (HPA) Aetiology of Encephalitis Study Group. Causes of encephalitis and differences in their clinical presentations in England: a multicentre, population-based prospective study. Lancet Infect Dis. 2010 Dec;10(12):835-44. doi: 10.1016/S1473-3099(10)70222-X. Epub 2010 Oct 15.

    PubMed 20952256

  • Tunkel AR, Glaser CA, Bloch KC, Sejvar JJ, Marra CM, Roos KL, Hartman BJ, Kaplan SL, Scheld WM, Whitley RJ; Infectious Diseases Society of America. The management of encephalitis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2008 Aug 1;47(3):303-27. doi: 10.1086/589747.

    PubMed 18582201

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dexamethasone in people with HSV Encephalitis, run by University Hospital, Grenoble at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jean-Paul STAHL, MD (04 76 76 68 13, jpstahl@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calcul of verbal memory score (time frame: at 6 months post randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03084783, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.

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