Steroids in Treatment of Viral Encephalitis

Encephalitis, Viral Clinical Trial

Official title:

Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04103684
• Other study ID #: LDVHDSE
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 30, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: Gamal Ali, Professor
• Phone: 01111686162
• Email: gamal.asker[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: August 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Viral

Intervention

Drug:
• Methylprednisolone
30mg per kg per day for 5 days followed by course of oral prednisolone
• Dexamethasone
0.6mg per kg perday for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (11)

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. — View Citation

Hjalmarsson A, Blomqvist P, Sköldenberg B. Herpes simplex encephalitis in Sweden, 1990-2001: incidence, morbidity, and mortality. Clin Infect Dis. 2007 Oct 1;45(7):875-80. Epub 2007 Aug 24. — View 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. — View 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. — View 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. Review. — View 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. Epub 2002 Jul 10. — View 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. — View 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. Review. — View 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. Review. — View 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. — View Citation

Whitley RJ. Viral encephalitis. N Engl J Med. 1990 Jul 26;323(4):242-50. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conscious level	Glasgow coma scale	5 days