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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35932399
Enrollment
704
Registered
2006-12-28
Start date
1996-12-26
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial meningitis Nervous System Diseases Inflammatory diseases of the central nervous system

Interventions

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

Sponsors

Alfred Kordelin Fund (Finland)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026