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
Scientific
HUCH Hospital for Children and Adolescents
Helsinki
00029
Finland
| heikki.peltola@hus.fi |
Study information
| Study design | Prospective randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Estudio GLI |
| Study objectives | 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(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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethasone, glycerol |
| Primary outcome measure | 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 study start date | 26/12/1996 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Months |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | 704 |
| Key inclusion criteria | Children at age two months to 16 years in whom bacterial meningitis was diagnosed and treated in the Institutions |
| Key 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 |
| Date of first enrolment | 26/12/1996 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- Argentina
- Brazil
- Dominican Republic
- Ecuador
- Finland
- Paraguay
- Venezuela
Study participating centre
HUCH Hospital for Children and Adolescents
Helsinki
00029
Finland
00029
Finland
Sponsor information
Alfred Kordelin Fund (Finland)
Not defined
Not defined
Mariankatu 7 A 3
Helsinki
00170
Finland
| toimisto@kordelin.fi | |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
