Evidence map›Paper›PMID 18959773›Full record

Trial reportBMC neurology2008

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].

Francisco Martinez-Torres, Sanjay Menon, Maria Pritsch, Norbert Victor, Ekkehart Jenetzky, Katrin Jensen, Eva Schielke, Erich Schmutzhard, Jan de Gans, Chin-Hee Chung and 4 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 3 pooled it
3.4field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

35 citing papers in PubMed, 3 syntheses or guidelines pooled it, 101 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Intravenous immunoglobulin for the treatment of childhood encephalitis.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Herpes Simplex Encephalitis: Lack of Clinical Benefit of Long-term Valacyclovir Therapy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2015
    Trial
  5. Review
  6. Review
  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. The Use of Adjunctive Steroids in Central Nervous Infections.Frontiers in cellular and infection microbiology · 2020
    Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Herpes Simplex Encephalitis: an Update.Current infectious disease reports · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 4 countries.

Francisco Martinez-TorresDepartment of Neurology, University of Heidelberg, Germany. Francisco.Martinez-Torres@UTSouthwestern.edu
Sanjay Menon
Maria Pritsch
Norbert Victor
Ekkehart Jenetzky
Katrin Jensen
Eva Schielke
Erich Schmutzhard
Jan de Gans
Chin-Hee Chung
Steffen Luntz
Werner Hacke
Uta Meyding-Lamadé
GACHE Investigators
Heidelberg University · DEKrankenhaus Nordwest · DEUniversity Hospital Heidelberg · DEAuguste-Viktoria-Klinik · DEContra Costa Health Services · USUniversität Innsbruck · ATUniversity of Amsterdam · NLZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe treatment of Herpes-simplex-virus-encephalitis (HSVE) remains a major unsolved problem in Neurology. Current gold standard for therapy is acyclovir, a drug that inhibits viral replication. Despite antiviral treatment, mortality remains up to 15%, less than 20% of patients are able to go back to work, and the majority of patients suffer from severe disability. This is a discouraging, unsatisfactory situation for treating physicians, the disabled patients and their families, and constitutes an enormous burden to the public health services. The information obtained from experimental animal research and from recent retrospective clinical observations, indicates that a substantial benefit in outcome can be expected in patients with HSVE who are treated with adjuvant dexamethasone. But currently there is no available evidence to support the routine use of adjuvant corticosteroid treatment in HSVE. A randomized multicenter trial is the only useful instrument to address this question.

designGACHE is a multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial of treatment with acyclovir and adjuvant dexamethasone, as compared with acyclovir and placebo in adults with HSVE. The statistical design will be that of a 3-stage-group sequential trial with potential sample size adaptation in the last stage.

conclusion372 patients with proven HSVE (positive HSV-DNA-PCR), aged 18 up to 85 years; with focal neurological signs no longer than 5 days prior to admission, and who give informed consent will be recruited from Departments of Neurology of academic medical centers in Germany, Austria and The Netherlands. Sample size will potentially be extended after the second interim analysis up to a maximum of 450 patients.

trial registrationCurrent Controlled TrialsISRCTN45122933.

Indexed as

AcyclovirAdultAgedAged, 80 and overAnti-Inflammatory AgentsAntiviral AgentsChemotherapy, AdjuvantDexamethasoneDouble-Blind MethodDrug Therapy, CombinationEncephalitis, Herpes SimplexGlucocorticoidsHumansMiddle AgedPatient SelectionResearch DesignAcyclovirAnti-Inflammatory AgentsAntiviral AgentsDexamethasoneGlucocorticoids

Identifiers

PMID18959773
PMCPMC2605746
OpenAlexW2132548307

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.