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

ISRCTN	ISRCTN45122933
DOI	https://doi.org/10.1186/ISRCTN45122933
EudraCT/CTIS number	2005-003201-81
Secondary identifying numbers	GFVT01026904 (GACHE)

Submission date: 23/08/2006
Registration date: 05/09/2006
Last edited: 17/09/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Uta Meyding-Lamade
Scientific

Steinbacher Hohl 2-26
Frankfurt am Main
60488
Germany

Phone	+49 (0)6976 0132 46
Email	meyding-lamade.uta@khnw.de

Study information

Study design	Multicentre, randomised, double-blind, placebo-controlled, parallel group clinical trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	German trial of Acyclovir and Corticosteroids in Herpes-simplex-virus-Encephalitis
Study acronym	GACHE
Study objectives	The GACHE trial aims to evaluate the effect on morbidity and mortality of early adjuvant corticosteroids (dexamethasone) in the treatment of adult patients with Herpes-Simplex-Virus-Encephalitis (HSVE).
Ethics approval(s)	Approval received from the Ethics Committee of the University of Heidelberg Medical Faculty on the 28th August 2006 (ref: AFmu-106/2006).
Health condition(s) or problem(s) studied	Herpes-Simplex-Virus-Encephalitis (HSVE)
Intervention	Treatment with acyclovir and adjuvant dexamethasone, as compared to treatment with acyclovir and placebo in adults with herpes-encephalitis.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Acyclovir and dexamethasone
Primary outcome measure	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 outcome measures	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
Overall study start date	01/10/2006
Completion date	31/07/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	372 patients, potential sample size extension up to 450 patients
Total final enrolment	41
Key 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
Key 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
Date of first enrolment	01/10/2006
Date of final enrolment	31/07/2011

Locations

Countries of recruitment

Austria
Germany
Netherlands

Study participating centre

Steinbacher Hohl 2-26

Frankfurt am Main
60488
Germany

Sponsor information

University Hospital of Heidelberg (Germany)
University/education

c/o Professor Werner Hacke
Department of Neurology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany

Phone	+49 (0)6221 56 8211
Email	werner.hacke@med.uni-heidelberg.de
Website	http://www.klinikum.uni-heidelberg.de/Neurologie-und-Poliklinik.600.0.html
"ROR"	https://ror.org/013czdx64

Funders

Funder type

Government

German Aerospace Center (Deutsches Zentrum fur Luft-und Raumfahrt e.V. [DLR]) (Germany)

No information available

Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01KG0504)
Government organisation / National government

Alternative name(s): Federal Ministry of Education and Research, BMBF
Location: Germany

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	29/10/2008	17/09/2019	Yes	No
Results article	results	01/12/2019	17/09/2019	Yes	No

Editorial Notes

17/09/2019: The following changes were made:
1. Publication reference and added.
2. EudraCT number added.
3. Total final enrolment added.