Abstract | BACKGROUND: In sub-Saharan Africa in the 1990s, more than 600,000 people had epidemic meningococcal meningitis, of whom 10% died. The current recommended treatment by WHO is short-course long-acting oily chloramphenicol. Continuation of the production of this drug is uncertain, so simple alternatives need to be found. We assessed whether the efficacy of single-dose treatment of ceftriaxone was non-inferior to that of oily chloramphenicol for epidemic meningococcal meningitis. METHODS: In 2003, we undertook a randomised, open-label, non-inferiority trial in nine health-care facilities in Niger. Participants with suspected disease who were older than 2 months were randomly assigned to receive either chloramphenicol or ceftriaxone. Primary outcome was treatment failure (defined as death or clinical failure) at 72 h, measured with intention-to-treat and per-protocol analyses. FINDINGS: Of 510 individuals with suspected disease, 247 received ceftriaxone, 256 received chloramphenicol, and seven were lost to follow-up. The treatment failure rate at 72 h for the intention-to-treat analysis was 9% (22 patients) for both drug groups (risk difference 0.3%, 90% CI -3.8 to 4.5). Case fatality rates and clinical failure rates were equivalent in both treatment groups (14 [6%] ceftriaxone vs 12 [5%] chloramphenicol). Results were also similar for both treatment groups in individuals with confirmed meningitis caused by Neisseria meningitidis. No adverse side-effects were reported. INTERPRETATION:
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Authors | N Nathan, T Borel, A Djibo, D Evans, S Djibo, J F Corty, M Guillerm, K P Alberti, L Pinoges, P J Guerin, D Legros |
Journal | Lancet (London, England)
(Lancet)
2005 Jul 23-29
Vol. 366
Issue 9482
Pg. 308-13
ISSN: 1474-547X [Electronic] England |
PMID | 16039333
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Anti-Bacterial Agents
- Chloramphenicol
- Ceftriaxone
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Topics |
- Adolescent
- Anti-Bacterial Agents
(administration & dosage)
- Ceftriaxone
(administration & dosage)
- Child
- Child, Preschool
- Chloramphenicol
(administration & dosage)
- Disease Outbreaks
- Female
- Humans
- Injections, Intramuscular
- Male
- Meningitis, Meningococcal
(drug therapy, epidemiology, mortality)
- Niger
(epidemiology)
- Survival Rate
- Treatment Failure
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