Plain English Summary
Not provided at time of registration
Trial website
http://www.klinikum.uni-heidelberg.de/index.php?id=4223&L=en
Contact information
Type
Scientific
Primary contact
Prof Uta Meyding-Lamade
ORCID ID
Contact details
Steinbacher Hohl 2-26
Frankfurt am Main
60488
Germany
+49 (0)6976 0132 46
meyding-lamade.uta@khnw.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GFVT01026904 (GACHE)
Study information
Scientific title
Acronym
GACHE
Study hypothesis
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
Approval received from the Ethics Committee of the University of Heidelberg Medical Faculty on the 28th August 2006 (ref: AFmu-106/2006).
Study design
Multicentre, randomised, double-blind, placebo-controlled, parallel group clinical trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Acyclovir and dexamethasone
Primary outcome measures
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 trial start date
01/10/2006
Overall trial end date
31/07/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
372 patients, potential sample size extension up to 450 patients
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
31/07/2011
Locations
Countries of recruitment
Austria, Germany, Netherlands
Trial participating centre
Steinbacher Hohl 2-26
Frankfurt am Main
60488
Germany
Sponsor information
Organisation
University Hospital of Heidelberg (Germany)
Sponsor details
c/o Professor Werner Hacke
Department of Neurology
Im Neuenheimer Feld 400
Heidelberg
69120
Germany
+49 (0)6221 56 8211
werner.hacke@med.uni-heidelberg.de
Sponsor type
University/education
Website
http://www.klinikum.uni-heidelberg.de/Neurologie-und-Poliklinik.600.0.html
Funders
Funder type
Government
Funder name
German Aerospace Center (Deutsches Zentrum fur Luft-und Raumfahrt e.V. [DLR]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany) (ref: 01KG0504)
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
government organisation
Funding Body Subtype
federal
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary