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
About this trial
This is an interventional treatment trial for Encephalitis, Viral
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 )
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
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
background
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
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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.
Results Reference
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PubMed Identifier
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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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