5 versus 10 days of treatment with ceftriaxone for bacterial meningitis in children: a double-blind randomised equivalence study
The Lancet - Early Online Publication, 06/07/2011
Molyneux E et al. - In children beyond the neonatal age-group with purulent meningitis caused by S pneumoniae, H influenzae type b, or N meningitidis who are stable by day 5 of ceftriaxone treatment, the antibiotic can be safely discontinued.Methods
- The authors did a multicountry, double-blind, placebo-controlled, randomised equivalence study of 5 versus 10 days of treatment with ceftriaxone in children aged 2 months to 12 years with purulent meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae type B, or Neisseria meningitidis.
- This study was done in ten paediatric referral hospitals in Bangladesh, Egypt, Malawi, Pakistan, and Vietnam.
- The authors randomly assigned children who were stable after 5 days of treatment, through site-balanced computer-generated allocation lists, to receive a further 5 days of ceftriaxone or placebo.
- Patients, their guardians, and staff were masked to study-group allocation.
- The primary outcomes were bacteriological failure or relapse.
- The analysis was per protocol.
- The authors included 1004 of 1027 children randomly assigned to study groups in the analyses; 496 received treatment with ceftriaxone for 5 days, and 508 for 10 days.
- In the 5-day treatment group, two children (one infected with HIV) had a relapse; there were no relapses in the 10-day treatment group and there were no bacteriological failures in either study group.
- Side-effects of antibiotic treatment were minor and similar in both groups.