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Steroids in Treatment of Viral Encephalitis

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ClinicalTrials.gov Identifier: NCT04103684
Recruitment Status : Not yet recruiting
First Posted : September 25, 2019
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
AA Nagy, Assiut University

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

Condition or disease Intervention/treatment Phase
Encephalitis, Viral Drug: Methylprednisolone Drug: Dexamethasone Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis
Estimated Study Start Date : March 30, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : August 30, 2021


Arm Intervention/treatment
Experimental: Patients will receive steroid pulse therapy Drug: Methylprednisolone
30mg per kg per day for 5 days followed by course of oral prednisolone
Other Name: Prednisolone

Active Comparator: Patients will receive low dose steroids Drug: Dexamethasone
0.6mg per kg perday for 5 days




Primary Outcome Measures :
  1. Conscious level [ Time Frame: 5 days ]
    Glasgow coma scale



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103684


Contacts
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Contact: Gamal Ali, Professor 01111686162 gamal.asker@med.au.edu.eg
Contact: Yasser Farouk, Lecturer 01111168123 yasser.resk@med.au.edu.eg

Sponsors and Collaborators
Assiut University
Publications:

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Responsible Party: AA Nagy, principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04103684    
Other Study ID Numbers: LDVHDSE
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Encephalitis, Viral
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Viral Diseases
Virus Diseases
Infectious Encephalitis
Central Nervous System Infections
Dexamethasone
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents