Journal Article

Adjuvant Glycerol and/or Dexamethasone to Improve the Outcomes of Childhood Bacterial Meningitis: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

Heikki Peltola, Irmeli Roine, Josefina Fernández, Inés Zavala, Silvia González Ayala, Antonio González Mata, Antonio Arbo, Rosa Bologna, Greta Miño, José Goyo, Eduardo López, Solange Dourado de Andrade and Seppo Sarna

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 45, issue 10, pages 1277-1286
Published in print November 2007 | ISSN: 1058-4838
Published online November 2007 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/522534
Adjuvant Glycerol and/or Dexamethasone to Improve the Outcomes of Childhood Bacterial Meningitis: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial

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Background. Despite favorable meta-analyses, no study involving third-generation cephalosporins for the treatment of childhood bacterial meningitis has documented a benefit of adjuvant dexamethasone therapy if the outcomes are examined individually.

Methods. We conducted a prospective, randomized, double-blind trial comparing adjuvant dexamethasone or glycerol with placebo in children aged from 2 months through 16 years in Latin America. Ceftriaxone was administered to all children; children were randomized to also receive dexamethasone intravenously, glycerol orally, both agents, or neither agent. Primary end points were death, severe neurological sequelae, or deafness, with the first 2 end points forming a composite end point. A subgroup analysis for Haemophilus influenzae type b meningitis was undertaken. Intention-to-treat analysis was performed using binary logistic regression models.

Results. H. influenzae type b, pneumococci, and meningococci were the main agents found among 654 patients; dexamethasone was given to 166, dexamethasone and glycerol were given to 159, glycerol was given to 166, and placebo was given to 163. No adjuvant therapy significantly affected death or deafness. In contrast, glycerol and dexamethasone plus glycerol reduced severe neurological sequelae, compared with placebo; the odds ratios were 0.31 (95% confidence interval [95% CI], 0.13–0.76; P = .010) and 0.39 (95% CI, 0.17–0.93; P = .033), respectively. For neurological sequelae and death, the odds ratios were 0.44 (95% CI, 0.25–0.76; P = .003) and 0.55 (95% CI, 0.32–0.93; P = .027), respectively. Dexamethasone therapy prevented deafness in patients with H. influenzae type b meningitis only if patients were divided grossly into dexamethasone recipients and nonrecipients and if timing between dexamethasone and ceftriaxone administration was not taken into account (odds ratio, 0.27; 95% CI, 0.09–0.77; P = .014).

Conclusion. Oral glycerol therapy prevents severe neurological sequelae in patients with childhood meningitis. Safety, availability, low cost, and oral administration also add to its usefulness, especially in resource-limited settings.

Journal Article.  4873 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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