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Steroids in Treatment of Viral Encephalitis

Primary Purpose

Encephalitis, Viral

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Methylprednisolone
Dexamethasone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Encephalitis, Viral

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 )

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Patients will receive steroid pulse therapy

    Patients will receive low dose steroids

    Arm Description

    Outcomes

    Primary Outcome Measures

    Conscious level
    Glasgow coma scale

    Secondary Outcome Measures

    Full Information

    First Posted
    September 24, 2019
    Last Updated
    January 28, 2020
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04103684
    Brief Title
    Steroids in Treatment of Viral Encephalitis
    Official Title
    Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 30, 2020 (Anticipated)
    Primary Completion Date
    March 30, 2021 (Anticipated)
    Study Completion Date
    August 30, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Encephalitis, Viral

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients will receive steroid pulse therapy
    Arm Type
    Experimental
    Arm Title
    Patients will receive low dose steroids
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Methylprednisolone
    Other Intervention Name(s)
    Prednisolone
    Intervention Description
    30mg per kg per day for 5 days followed by course of oral prednisolone
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Intervention Description
    0.6mg per kg perday for 5 days
    Primary Outcome Measure Information:
    Title
    Conscious level
    Description
    Glasgow coma scale
    Time Frame
    5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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 )
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gamal Ali, Professor
    Phone
    01111686162
    Email
    gamal.asker@med.au.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yasser Farouk, Lecturer
    Phone
    01111168123
    Email
    yasser.resk@med.au.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17806053
    Citation
    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.
    Results Reference
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    PubMed Identifier
    15804262
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12115090
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19929384
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    9328248
    Citation
    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.
    Results Reference
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    PubMed Identifier
    2195341
    Citation
    Whitley RJ. Viral encephalitis. N Engl J Med. 1990 Jul 26;323(4):242-50. doi: 10.1056/NEJM199007263230406. No abstract available.
    Results Reference
    background
    PubMed Identifier
    2346392
    Citation
    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.
    Results Reference
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    PubMed Identifier
    18582201
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22120595
    Citation
    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.
    Results Reference
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    PubMed Identifier
    20236175
    Citation
    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.
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    PubMed Identifier
    24009096
    Citation
    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.
    Results Reference
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    Steroids in Treatment of Viral Encephalitis

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