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
-
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.
-
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.
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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.