Bacterial meningitis Nervous System Diseases Inflammatory diseases of the central nervous system
Conditions
Interventions
All children to receive ceftriaxone once daily for 1 - 5 days.
From 6 - 10 days children will be randomised to receive the same dose of ceftriaxone or placebo.
Sponsors
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 2 - 71 months (as of 11/10/07 the upper age limit was increased to 144 months) 2. Weight 3.0 kg - 18.5 kg (as of 11/10/07 the upper weight limit was increased) 3. Children of acute bacterial meningitis with positive Cerebrospinal Fluid (CSF) culture or latex for H. influenzae, St. pneumoniae, N. meningitidis 4. If CSF culture negative, then CSF White Blood Cell count (WBC) greater than 10/ml and blood culture positive by day 3 5. Treatment with injectable ceftriaxone since admission 6. Informed consent from parent/guardian
Exclusion criteria
Exclusion criteria: 1. Neurological conditions 2. Known cerebral palsy, immunodeficiency or chronic afebrile seizure disorder 3. Progressive brain degenerative disorder 4. Cranial fracture with or without CSF leak 5. Known cyanotic heart disorder 6. Known deafness prior to admission 7. Evidence of measles, mumps or chicken pox present 8. Child randomised to the study before 9. Illness more than 7 days 10. Allergic to cephalosporins 11. Lives outside follow-up area of study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of bacteriologic failure defined as: 1. Cerebrospinal Fluid (CSF) or blood culture positive* on day 6 to 40 for original organism, or 2. CSF or blood culture positive on days 6 to 40 in a patient who had culture negative bacterial meningitis Note: Repeat lumber puncture will be done between 48-72 hours of admission. A repeat blood cultures will only be done if condition of the patient requires it. *for H. influenzae, S. pneumoniae, N. meningitidis | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Perceived treatment failure 2. Hearing loss: Day 40 screen Otoacoustic Emissions (OAE), Auditory Brainstem Response (ABR) greater than 40 db 3. Blindness diagnosed at day 40 4. Motor deficit at day 40 including: 4.1. Two or more abnormalities of tone or strength in any of the limbs or neck, or 4.2. Any palsy of VI or VII cranial nerves 5. Developmental score: abnormal developmental screening on day 190 + 30 days as evaluated by Denver Screening method 6. Seizures: any seizure without fever presenting on days 10 to 40 or 41 to 190 + 30 days 7. Hydrocephalus: defined as any patient with ventriculo-peritoneal shunting or clinical signs and head circumference measurements consistent with hydrocephalous and the perceived need of ventricular derivation 8. Death of an enrolled patient by any cause between days 6 - 40 9. Death of an enrolled patient by any cause between 41 - 190 days 10. Bacterial pathogen | — |
Countries
Bangladesh, Egypt, Malawi, Pakistan, South Africa, Viet Nam
Outcome results
None listed