The German trial on Aciclovir and Corticosteroids in Herpes-simplex-virus-Encephalitis (GACHE): a multicenter, randomize
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(2019) 1:26
Neurological Research and Practice
RESEARCH ARTICLE
Open Access
The German trial on Aciclovir and Corticosteroids in Herpes-simplex-virusEncephalitis (GACHE): a multicenter, randomized, double-blind, placebocontrolled trial U. Meyding-Lamadé1,2*†, C. Jacobi1†, F. Martinez-Torres1,2, T. Lenhard2, B. Kress3, M. Kieser5, C. Klose4, K. Einhäupl5, J. Bösel11, M-B Mackert6, V. Homberg19, C. Koennecke7, G. Weißheit7, D. Claus8,18, B. Kieseier9, J. Bardutzky21, T. Neumann-Haefelin17, M. W. Lorenz1,9, H. Steinmetz9, C. Gerloff10, D. Schneider12, A. Grau13, M. Klein14, R. Dziewas15, U. Bogdahn20, W. Jakob15, R. Linker15, K. Fuchs15, A. Sander4, S. Luntz16, T. Hoppe-Tichy20, D. F. Hanley23, R. von Kummer22 and E. Craemer1
Abstract Introduction: Comprehensive treatment of Herpes-simplex-virus-encephalitis (HSVE) remains a major clinical challenge. The current therapy gold standard is aciclovir, a drug that inhibits viral replication. Despite antiviral treatment, mortality remains around 20% and a majority of survivors suffer from severe disability. Experimental research and recent retrospective clinical observations suggest a favourable therapy response to adjuvant dexamethasone. Currently there is no randomized clinical trial evidence, however, to support the routine use of adjuvant corticosteroid treatment in HSVE. Methods: The German trial of Aciclovir and Corticosteroids in Herpes-simplex-virus-Encephalitis (GACHE) studied the effect of adjuvant dexamethasone versus placebo on top of standard aciclovir treatment in adult patients aged 18 up to 85 years with proven HSVE in German academic centers of Neurology in a randomized and double blind fashion. The trial was open from November 2007 to December 2012. The initially planned sample size was 372 patients with the option to increase to up to 450 patients after the second interim analysis. The primary endpoint was a binary functional outcome after 6 months assessed using the modified Rankin scale (mRS 0–2 vs. 3–6). Secondary endpoints included mortality after 6 and 12 months, functional outcome after 6 months measured with the Glasgow outcome scale (GOS), functional outcome after 12 months measured with mRS and GOS, quality of life as measured with the EuroQol 5D instrument after 6 and 12 months, neuropsychological testing after 6 months, cranial magnetic resonance imaging findings after 6 months, seizures up to day of discharge or at the latest at day 30, and after 6 and 12 months. (Continued on next page)
* Correspondence: [email protected] † U. Meyding-Lamadé and C. Jacobi contributed equally to this work. 1 Department of Neurology, Krankenhaus Nordwest, Frankfurt, Germany 2 Department of Neurology, University of Heidelberg, Heidelberg, Germany Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
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