Intravenous dexamethasone versus oral glycerol versus placebo in reducing auditory sequelae of childhood bacterial meningitis

ISRCTN ISRCTN35932399
DOI https://doi.org/10.1186/ISRCTN35932399
Secondary identifying numbers 1
Submission date
08/12/2006
Registration date
28/12/2006
Last edited
08/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Heikki Peltola
Scientific

HUCH Hospital for Children and Adolescents
Helsinki
00029
Finland

Email heikki.peltola@hus.fi

Study information

Study designProspective randomised double-blind placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study acronymEstudio GLI
Study objectivesOral 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(s)Ministério da Saude, Comissão Nacional de Ética em Pesquisa - CONEP (ref: Parecer No. 1137/2001, Registro CONEP 2339), approval date: Oct. 2, 2001.
Health condition(s) or problem(s) studiedBacterial meningitis
InterventionAdjuvant 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Dexamethasone, glycerol
Primary outcome measure1. Death
2. Severe neurological sequelae
3. Hearing impairment
Secondary outcome measuresComposite endpoints:
1. Severe neurological sequelae or death
2. Subanalysis on Hib meningitis with or without prior antimicrobials
Overall study start date26/12/1996
Completion date31/12/2003

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Months
Upper age limit16 Years
SexBoth
Target number of participants704
Key inclusion criteriaChildren at age two months to 16 years in whom bacterial meningitis was diagnosed and treated in the Institutions
Key exclusion criteria1. Recent head injury
2. Previous neurosurgery
3. Neurological diseases
4. Immunosuppression
5. Known hearing impairment
6. More than one dose of parenteral anti-microbial
Date of first enrolment26/12/1996
Date of final enrolment31/12/2003

Locations

Countries of recruitment

  • Argentina
  • Brazil
  • Dominican Republic
  • Ecuador
  • Finland
  • Paraguay
  • Venezuela

Study participating centre

HUCH Hospital for Children and Adolescents
Helsinki
00029
Finland

Sponsor information

Alfred Kordelin Fund (Finland)
Not defined

Mariankatu 7 A 3
Helsinki
00170
Finland

Email toimisto@kordelin.fi
ROR logo "ROR" https://ror.org/0107h6s84

Funders

Funder type

Industry

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

No information available

GlaxoSmithKline company (in initial phase) (Finland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/11/2007 Yes No
Results article results 01/01/2009 Yes No
Results article results 01/01/2010 Yes No