Dexamethasone in Vietnamese adolescents and adults with bacterial meningitis

N Engl J Med. 2007 Dec 13;357(24):2431-40. doi: 10.1056/NEJMoa070852.

Abstract

Background: It is uncertain whether all adults with bacterial meningitis benefit from treatment with adjunctive dexamethasone.

Methods: We conducted a randomized, double-blind, placebo-controlled trial of dexamethasone in 435 patients over the age of 14 years who had suspected bacterial meningitis. The goal was to determine whether dexamethasone reduced the risk of death at 1 month and the risk of death or disability at 6 months.

Results: A total of 217 patients were assigned to the dexamethasone group, and 218 to the placebo group. Bacterial meningitis was confirmed in 300 patients (69.0%), probable meningitis was diagnosed in 123 patients (28.3%), and an alternative diagnosis was made in 12 patients (2.8%). An intention-to-treat analysis of all the patients showed that dexamethasone was not associated with a significant reduction in the risk of death at 1 month (relative risk, 0.79; 95% confidence interval [CI], 0.45 to 1.39) or the risk of death or disability at 6 months (odds ratio, 0.74; 95% CI, 0.47 to 1.17). In patients with confirmed bacterial meningitis, however, there was a significant reduction in the risk of death at 1 month (relative risk, 0.43; 95% CI, 0.20 to 0.94) and in the risk of death or disability at 6 months (odds ratio, 0.56; 95% CI, 0.32 to 0.98). These effects were not found in patients with probable bacterial meningitis. Results of multivariate analysis indicated that dexamethasone treatment for patients with probable bacterial meningitis was significantly associated with an increased risk of death at 1 month, an observation that may be explained by cases of tuberculous meningitis in the treatment group.

Conclusions: Dexamethasone does not improve the outcome in all adolescents and adults with suspected bacterial meningitis; a beneficial effect appears to be confined to patients with microbiologically proven disease, including those who have received prior treatment with antibiotics. (Current Controlled Trials number, ISRCTN42986828 [controlled-trials.com] .).

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / therapeutic use
  • Ceftriaxone / therapeutic use
  • Cerebrospinal Fluid / microbiology
  • Dexamethasone / adverse effects
  • Dexamethasone / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Glucocorticoids / adverse effects
  • Glucocorticoids / therapeutic use*
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Meningitis, Bacterial / drug therapy*
  • Meningitis, Bacterial / microbiology
  • Meningitis, Bacterial / mortality
  • Middle Aged
  • Multivariate Analysis
  • Treatment Failure
  • Vietnam

Substances

  • Anti-Bacterial Agents
  • Glucocorticoids
  • Ceftriaxone
  • Dexamethasone

Associated data

  • ISRCTN/ISRCTN42986828