Comparison of 5 versus 10 days of ceftriaxone therapy for bacterial meningitis in children: multicentre study in Bangladesh, Malawi, Pakistan, South Africa, Vietnam and Egypt
- Conditions
- Bacterial meningitisNervous System DiseasesInflammatory diseases of the central nervous system
- Registration Number
- ISRCTN38717320
- Lead Sponsor
- The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1500
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method