Condition category
Infections and Infestations
Date applied
23/08/2006
Date assigned
05/09/2006
Last edited
31/03/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes