Condition category
Nervous System Diseases
Date applied
08/12/2006
Date assigned
28/12/2006
Last edited
08/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Heikki Peltola

ORCID ID

Contact details

HUCH Hospital for Children and Adolescents
Helsinki
00029
Finland
heikki.peltola@hus.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Acronym

Estudio GLI

Study hypothesis

Oral glycerol (GLY) may be at least as efficaceous as parenteral dexamethasone (DXM) in reducing auditory and other sequealae caused be bacterial meningitis of childhood.

Ethics approval

Ministério da Saude, Comissão Nacional de Ética em Pesquisa - CONEP (ref: Parecer No. 1137/2001, Registro CONEP 2339), approval date: Oct. 2, 2001.

Study design

Prospective randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Bacterial meningitis

Intervention

Adjuvant medication with intravenous DXM, oral GLY, both, or neither agent.

4 arms:
Arm 1: DXM + placebo (PLA)
Arm 2: DXM + GLY
Arm 3: GLY + PLA
Arm 4: PLA + PLA

Intervention type

Drug

Phase

Not Specified

Drug names

Dexamethasone, glycerol

Primary outcome measures

1. Death
2. Severe neurological sequelae
3. Hearing impairment

Secondary outcome measures

Composite endpoints:
1. Severe neurological sequelae or death
2. Subanalysis on Hib meningitis with or without prior antimicrobials

Overall trial start date

26/12/1996

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Children at age two months to 16 years in whom bacterial meningitis was diagnosed and treated in the Institutions

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

704

Participant exclusion criteria

1. Recent head injury
2. Previous neurosurgery
3. Neurological diseases
4. Immunosuppression
5. Known hearing impairment
6. More than one dose of parenteral anti-microbial

Recruitment start date

26/12/1996

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Argentina, Brazil, Dominican Republic, Ecuador, Paraguay, Venezuela

Trial participating centre

HUCH Hospital for Children and Adolescents
Helsinki
00029
Finland

Sponsor information

Organisation

Alfred Kordelin Fund (Finland)

Sponsor details

Mariankatu 7 A 3
Helsinki
00170
Finland
toimisto@kordelin.fi

Sponsor type

Not defined

Website

Funders

Funder type

Industry

Funder name

Alfred Kordelin, Päivikki and Sakari Sohlberg, and Sigfird Jusélius Funds (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

GlaxoSmithKline company (in initial phase) (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17968821
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18990528
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20008417

Publication citations

  1. Results

    Peltola H, Roine I, Fernández J, Zavala I, Ayala SG, Mata AG, Arbo A, Bologna R, Miño G, Goyo J, López E, de Andrade SD, Sarna S, Adjuvant glycerol and/or dexamethasone to improve the outcomes of childhood bacterial meningitis: a prospective, randomized, double-blind, placebo-controlled trial., Clin. Infect. Dis., 2007, 45, 10, 1277-1286, doi: 10.1086/522534.

  2. Results

    Peltola H, Roine I, Fernández J, González Mata A, Zavala I, Gonzalez Ayala S, Arbo A, Bologna R, Goyo J, López E, Miño G, Dourado de Andrade S, Sarna S, Jauhiainen T, Hearing impairment in childhood bacterial meningitis is little relieved by dexamethasone or glycerol., Pediatrics, 2010, 125, 1, e1-8, doi: 10.1542/peds.2009-0395.

  3. Roine I, Saukkoriipi A, Leinonen M, Peltola H, , Microbial genome count in cerebrospinal fluid compared with clinical characteristics in pneumococcal and Haemophilus influenzae type b meningitis in children., Diagn. Microbiol. Infect. Dis., 2009, 63, 1, 16-23, doi: 10.1016/j.diagmicrobio.2008.09.005.

Additional files

Editorial Notes