Steroids in Treatment of Viral Encephalitis

NCT04103684 | Unknown Phase 4

• 1 other identifier: LDVHDSE
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Encephalitis, Viral

Outcome Measures

Primary Outcomes (1)

• Conscious level

  Glasgow coma scale

  5 days

Study Arms (2)

Patients will receive steroid pulse therapy

EXPERIMENTAL

Drug: Methylprednisolone

Patients will receive low dose steroids

ACTIVE COMPARATOR

Drug: Dexamethasone

Interventions

Methylprednisolone DRUG

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

Also known as: Prednisolone

Patients will receive steroid pulse therapy

Dexamethasone DRUG

0.6mg per kg perday for 5 days

Patients will receive low dose steroids

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients who attending Neurology unit in Assiut University Children Hospital and diagnosed as viral encephalitis.
• Age 1month : 18 year .
• Both sexes.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

• 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.

  PMID: 17806053 BACKGROUND

• 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.

  PMID: 15804262 BACKGROUND

• 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.

  PMID: 12115090 BACKGROUND

• 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.

  PMID: 19929384 BACKGROUND

• 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.

  PMID: 9328248 BACKGROUND

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

  PMID: 2195341 BACKGROUND

• 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.

  PMID: 2346392 BACKGROUND

• 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.

  PMID: 18582201 BACKGROUND

• 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.

  PMID: 22120595 BACKGROUND

• 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.

  PMID: 20236175 BACKGROUND

• 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.

  PMID: 24009096 BACKGROUND

MeSH Terms

Conditions

Encephalitis, Viral

Interventions

Methylprednisolone; Prednisolone; Dexamethasone

Condition Hierarchy (Ancestors)

Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Infectious Encephalitis; Virus Diseases; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Gamal Ali, Professor

CONTACT

01111686162; gamal.asker@med.au.edu.eg

Yasser Farouk, Lecturer

CONTACT

01111168123; yasser.resk@med.au.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 25, 2019
• Study Start: March 30, 2020
• Primary Completion: March 30, 2021
• Study Completion: August 30, 2021
• Last Updated: January 29, 2020

Record last verified: 2020-01