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临床试验/NCT04103684
NCT04103684Unknown4 期

Low Dose Versus High Dose Steroids in Treatment of Viral Encephalitis

Assiut University0 个研究点目标入组 100 人开始时间: 2020年3月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
主要终点
Conscious level

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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 )

研究组 & 干预措施

Patients will receive steroid pulse therapy

Experimental

干预措施: Methylprednisolone (Drug)

Patients will receive low dose steroids

Active Comparator

干预措施: Dexamethasone (Drug)

结局指标

主要结局

Conscious level

时间窗: 5 days

Glasgow coma scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

AA Nagy

principle investigator

Assiut University

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Steroids in Treatment of Viral Encephalitis | 临床试验