GACHE: German trial of Acyclovir and Corticosteroids in Herpes-simplex-virus-Encephalitis. A multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial. - GACHE

niversitätsklinikum Heidelberg0 个研究点目标入组 450 人开始时间: 2007年1月19日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•? Age 18 up to and including 85 years
•? laboratory – proven diagnosis of herpes-simplex-virus-encephalitis (PCR detection of HSV-DNA in the CSF or positive HSV-ASI (>1,5) in the CSF)
•? focal neurological signs for not more than 5 days
•? informed consent
•? women of childbearing potential: negative pregnancy testing in urine
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•? Systemic treatment with corticosteroids in the last 6 months, however allowed upto 20mg (prednisolone) oral intake
•? Current use of corticosteroids
•? History of hypersensitivity to corticosteroids
•? Two fixed dilated pupils
•? Pre-event score on the modified Rankin Scale > 2 or on the Barthel Index < 95.
•? Pregnancy
•? women of childbearing potential who are not using a highly effective birth control method
•? Breast feeding women
•? Recent history of active tuberculosis or systemic fungal infection
•? Recent history of head trauma or neurosurgery
•? Recent history of peptic ulcer disease
•? Life expectancy < 3 years.
•? Other serious illness that may confound treatment assessment
•? simultaneous participation in another clinical trial
•? previous participation in another clinical trial in the last 30 days
•? previous participation in this clinical trial
•? acute viral infections other than HSVE (herpes zoster, poliomyelitis, chickenpox)
•? HBsAg-positive chronic active hepatitis
•? approx. 8 weeks before to 2 weeks after prophylactic vaccination
•? lymphadenitis following BCG vaccination.

发起方

niversitätsklinikum Heidelberg