German trial of Acyclovir and Corticosteroids in Herpes-simplex-virus-Encephalitis

Conditions

Herpes-Simplex-Virus-Encephalitis (HSVE) Infections and Infestations Encephalitis

Thomas Whitfield, Cristina Fernández, Kelly Davies, Sylviane Defres, Michael J. Griffiths et al. (20 authors)

BMJ Open2021-07-0133 citations

10.1136/bmjopen-2020-041808

Protocol for German trial of Acyclovir and corticosteroids in Herpes-simplex-virus-encephalitis (GACHE): a multicenter, multinational, randomized, double-blind, placebo-controlled German, Austrian and Dutch trial [ISRCTN45122933].

Martinez-Torres F, Menon S, Pritsch M, Victor N, Jenetzky E, Jensen K, Schielke E, Schmutzhard E, de Gans J, Chung CH, Luntz S, Hacke W, Meyding-Lamadé U, GACHE Investigators.

2008-10-2961 citations

10.1186/1471-2377-8-40

Interventions

Treatment with acyclovir and adjuvant dexamethasone, as compared to treatment with acyclovir and placebo in adults with herpes-encephalitis.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Proven herpes-encephalitis (positive Herpes Simplex Virus-Deoxyribonucleic Acid-Polymerase Chain Reaction [HSV-DNA-PCR]) 2. Aged between 18 and 85 3. Focal neurological signs not longer than five days prior to admission 4. Informed consent Added as of 05/04/2007: 5. Women of childbearing potential: negative pregnancy testing in urine

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to corticosteroids 2. Systemic corticosteroid treatment within the last six months or at present time 3. Two fixed dilated pupils 4. Pre-event score modified Rankin Scale (mRS) more than two or Barthel Index less than 95 5. Pregnancy 6. Breast feeding women 7. Recent history of active tuberculosis or systemic fungal infection 8. Recent head trauma/neurosurgery/peptic ulcer disease 9. Life expectancy less than three years 10. Other serious illness that confound treatment assessment 11. Simultaneous participation in another clinical trial 12. Previous participation in another clinical trial in the last 30 days 13. Previous participation in this clinical trial Added as of 05/04/2007: 14. Women of childbearing potential who are not using a highly effective birth control method 15. Acute viral infections other than HSVE (herpes zoster, poliomyelitis, chickenpox), Hepatitis B surface Antigen (HBsAg)-positive chronic active hepatitis, approximately eight weeks before to two weeks after prophylactic vaccination, lymphadenitis following Bacille Calmette Guérin (BCG) vaccination

Design outcomes

Primary

Measure	Time frame
Binary functional outcome after six months measured by the mRS, a seven-point-scale zero to six. A mRS-score of three to six will be seen as an unfavourable outcome.	—

Secondary

Measure	Time frame
1. Mortality after six and 12 months 2. Functional outcome after six months measured by Glasgow Outcome Scale (GOS) and quality of life (EuroQol 5D) 3. Functional outcome after 12 months (mRS, GOS) and quality of life (EuroQol 5D) 4. Neuropsychological testing after six months, cranial Magnetic Resonance Imaging (MRI) findings after six months 5. Seizures up to day of discharge or at the latest at day 30, and after six and 12 months	—

Measure

Time frame

1. Mortality after six and 12 months 2. Functional outcome after six months measured by Glasgow Outcome Scale (GOS) and quality of life (EuroQol 5D) 3. Functional outcome after 12 months (mRS, GOS) and quality of life (EuroQol 5D) 4. Neuropsychological testing after six months, cranial Magnetic Resonance Imaging (MRI) findings after six months 5. Seizures up to day of discharge or at the latest at day 30, and after six and 12 months

—

Countries

Austria, Germany, Netherlands

Outcome results

None listed