AzTrials
AzTrials

Encephalitis, ViralPhase 4NCT04103684

Steroids in Treatment of Viral Encephalitis

A Phase 4 study testing Methylprednisolone and Dexamethasone in people with Encephalitis, Viral, run by Assiut University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

acute viral encephalitis is used to describe restricted CNS involvement (namely, involvement of the brain, sparing the meninges) Read more about this study

Who is it for?
Ages 1 month to 18 years
Conditions the study is for
Encephalitis, Viral
What is being tested?
Methylprednisolone and Dexamethasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
30 Mar 2020to 30 Aug 2021
Phase
Phase 4
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 1 month to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Pediatric patients who attending Neurology unit in Assiut University Children Hospital and diagnosed as viral encephalitis.
  • Age 1month : 18 year .
  • Both sexes.
  • Diagnosis of viral encephalitis will be confirmed by clinical picture ,investigations and exclusion of other causes of encephalopathy

Who cannot join

  • Autoimmune encephalitis
  • Renal failure (any patient with abnormal renal function tests will be excluded)
  • Hepatic failure ( any patient with abnormal liver function tests will be excluded)
  • Metabolic disorders (any patient with abnormal level of ammonia and lactate )

Trial locations and contacts

No sites are listed yet.

Gamal Ali, Professor contact

01111686162

gamal.asker@med.au.edu.eg

Yasser Farouk, Lecturer contact

01111168123

yasser.resk@med.au.edu.eg

About this study

Official title: Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis

acute viral encephalitis is used to describe restricted CNS involvement (namely, involvement of the brain, sparing the meninges)

Read the detailed description

Viral encephalitis is a medical emergency The spectrum of brain involvement and the prognosis are dependent mainly on the specific pathogen and the immunological state of the host.

Although specific therapy is limited to only several viral agents, correct immediate diagnosis and introduction of symptomatic and specific therapy has a dramatic influence upon survival and reduces the extent of permanent brain injury in survivors Epidemiologic studies estimate the incidence of viral encephalitis at 3.5 to 7.4 per 100,000 persons per year. Overall, viruses are the most common cause of encephalitis.

The Centers for Disease Control and Prevention (CDC) estimates an annual incidence of approximately 20,000 new cases of encephalitis in the United States; most are mild in nature. The mortality depends largely on the etiologic agent of the encephalitis.

Herpes simplex virus (HSV) encephalitis (HSVE) is the most common cause of sporadic encephalitis in humans. More than 90% of HSVE cases are attributable to HSV type-1 (HSV-1). Approximately 5% of them are caused by HSV type-2 HSVE is a severe disease, often leading to high morbidity (40%) and mortality (up to 15% in treated cases and 70% in untreated cases) Patients with encephalitis have an altered mental status ranging from subtle deficits to complete unresponsiveness. The typical clinical presentation includes a rapid onset of fever and impaired consciousness, often accompanied by focal neurologic signs and seizures.

The current treatment of choice is the viral replication inhibitor acyclovir. Although highly effective in reducing mortality, it only results in complete recovery in one-half of patients . Steroid therapy as an adjunctive therapy in HSVE has good anti inflammatory effect. Steroid therapy has both anti inflammatory and immunosuppressive property.

The diagnosis of viral encephalitis is suspected in the context of a febrile disease accompanied by headache, altered level of consciousness, and symptoms and signs of cerebral dysfunction. These may consist of abnormalities that can be categorized into four: cognitive dysfunction (acute memory disturbances), behavioural changes (disorientation, hallucinations, psychosis, personality changes, agitation), focal neurological abnormalities (such as anosmia, dysphasia, hemiparesis, hemianopia etc.) and seizures. After the diagnosis is suspected, the approach should consist of obtaining a meticulous history and a careful general and neurological examination.

Medical subject headings
Encephalitis, Viral

What participants receive

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

  • MethylprednisoloneDrug

    Also called Prednisolone

    30mg per kg per day for 5 days followed by course of oral prednisolone

  • DexamethasoneDrug

    0.6mg per kg perday for 5 days

Study groups in NCT04103684
Study groupRoleWhat they receive
Patients will receive steroid pulse therapyExperimentalNot described
Receives: Drug: Methylprednisolone
Patients will receive low dose steroidsActive comparatorNot described
Receives: Drug: Dexamethasone

What is being measured

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

  1. Conscious level

    Glasgow coma scale

    Measured: 5 days

Timeline

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

  1. First posted25 Sep 2019
  2. Study start30 Mar 2020 (estimated)
  3. Primary completion30 Mar 2021 (estimated)
  4. Study completion30 Aug 2021 (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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04103684
Sponsor's protocol ID
LDVHDSE
Status last verified
Jan 2020
First submitted
24 Sep 2019
Last updated
29 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hjalmarsson A, Blomqvist P, Skoldenberg B. Herpes simplex encephalitis in Sweden, 1990-2001: incidence, morbidity, and mortality. Clin Infect Dis. 2007 Oct 1;45(7):875-80. doi: 10.1086/521262. Epub 2007 Aug 24.

    PubMed 17806053

  • Steiner I, Budka H, Chaudhuri A, Koskiniemi M, Sainio K, Salonen O, Kennedy PG. Viral encephalitis: a review of diagnostic methods and guidelines for management. Eur J Neurol. 2005 May;12(5):331-43. doi: 10.1111/j.1468-1331.2005.01126.x.

    PubMed 15804262

  • Raschilas F, Wolff M, Delatour F, Chaffaut C, De Broucker T, Chevret S, Lebon P, Canton P, Rozenberg F. Outcome of and prognostic factors for herpes simplex encephalitis in adult patients: results of a multicenter study. Clin Infect Dis. 2002 Aug 1;35(3):254-60. doi: 10.1086/341405. Epub 2002 Jul 10.

    PubMed 12115090

  • Mailles A, Stahl JP; Steering Committee and Investigators Group. Infectious encephalitis in france in 2007: a national prospective study. Clin Infect Dis. 2009 Dec 15;49(12):1838-47. doi: 10.1086/648419.

    PubMed 19929384

  • McGrath N, Anderson NE, Croxson MC, Powell KF. Herpes simplex encephalitis treated with acyclovir: diagnosis and long term outcome. J Neurol Neurosurg Psychiatry. 1997 Sep;63(3):321-6. doi: 10.1136/jnnp.63.3.321.

    PubMed 9328248

  • Whitley RJ. Viral encephalitis. N Engl J Med. 1990 Jul 26;323(4):242-50. doi: 10.1056/NEJM199007263230406. No abstract available.

    PubMed 2195341

  • Gordon B, Selnes OA, Hart J Jr, Hanley DF, Whitley RJ. Long-term cognitive sequelae of acyclovir-treated herpes simplex encephalitis. Arch Neurol. 1990 Jun;47(6):646-7. doi: 10.1001/archneur.1990.00530060054017.

    PubMed 2346392

  • 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

  • Solomon T, Michael BD, Smith PE, Sanderson F, Davies NW, Hart IJ, Holland M, Easton A, Buckley C, Kneen R, Beeching NJ; National Encephalitis Guidelines Development and Stakeholder Groups. Management of suspected viral encephalitis in adults--Association of British Neurologists and British Infection Association National Guidelines. J Infect. 2012 Apr;64(4):347-73. doi: 10.1016/j.jinf.2011.11.014. Epub 2011 Nov 18.

    PubMed 22120595

  • Steiner I, Budka H, Chaudhuri A, Koskiniemi M, Sainio K, Salonen O, Kennedy PG. Viral meningoencephalitis: a review of diagnostic methods and guidelines for management. Eur J Neurol. 2010 Aug;17(8):999-e57. doi: 10.1111/j.1468-1331.2010.02970.x. Epub 2010 Mar 3.

    PubMed 20236175

  • Ramos-Estebanez C, Lizarraga KJ, Merenda A. A systematic review on the role of adjunctive corticosteroids in herpes simplex virus encephalitis: is timing critical for safety and efficacy? Antivir Ther. 2014;19(2):133-9. doi: 10.3851/IMP2683. Epub 2013 Sep 6.

    PubMed 24009096

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methylprednisolone and Dexamethasone in people with Encephalitis, Viral, run by Assiut University.

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 4 inclusion and 4 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 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Gamal Ali, Professor (01111686162, gamal.asker@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conscious level (time frame: 5 days). 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 NCT04103684, which also lists 11 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 29 Jan 2020.

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