de Gans dexamethasone meningitis trial
Dexamethasone in adults with bacterial meningitis
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Overview
In adults with acute bacterial meningitis, adjunctive dexamethasone reduced unfavorable 8-week outcomes (primary); death was also lower versus placebo.
Clinical takeaway
Give dexamethasone before or with the first antibiotic in adults with acute bacterial meningitis. The primary 8-week Glasgow Outcome Scale result favored dexamethasone, and gastrointestinal bleeding was not increased.
Key result
On intention-to-treat analysis, dexamethasone reduced the primary unfavorable 8-week outcome (RR 0.59, 95% CI 0.37-0.94; P=0.03). Death was also lower (RR 0.48, 95% CI 0.24-0.96; P=0.04).
Practice impact
In adults with acute bacterial meningitis, start dexamethasone 10 mg with or just before the first antibiotic and continue every 6 hours for four days.
Evidence
Study design
Prospective, randomized, double-blind, multicenter trial of adjuvant dexamethasone versus placebo, analyzed by intention to treat.
Enrollment
301
Follow-up
Eight weeks.
Geography
Not listed
Clinical question
Does adjunctive dexamethasone improve 8-week neurologic outcome compared with placebo in adults with acute bacterial meningitis?
Population
- Adults with acute bacterial meningitis.
Intervention
Dexamethasone 10 mg administered 15 to 20 minutes before or with the first antibiotic dose, then every 6 hours for four days.
Comparator
Matching placebo on the same schedule.
Primary outcome
Glasgow Outcome Scale score at eight weeks (5, favorable, versus 1 to 4, unfavorable).
Adjunctive dexamethasone reduced the risk of an unfavorable 8-week outcome compared with placebo on intention-to-treat analysis.
Relative risk / 0.59 / 95% CI 0.37-0.94 / p=0.03
Key results
- Of 301 randomized patients, 157 were assigned to dexamethasone and 144 to placebo.
- Dexamethasone reduced the risk of an unfavorable 8-week outcome, the primary end point (relative risk 0.59, 95% CI 0.37-0.94; P=0.03). Mortality was also lower (relative risk of death 0.48, 95% CI 0.24-0.96; P=0.04).
- Among patients with pneumococcal meningitis (subgroup by causative organism), unfavorable outcomes were 26% with dexamethasone vs 52% with placebo (relative risk 0.50, 95% CI 0.30-0.83; P=0.006).
- Gastrointestinal bleeding occurred in 2 patients in the dexamethasone group and 5 in the placebo group.
Harms
- Gastrointestinal bleeding occurred in 2 patients assigned to dexamethasone and 5 assigned to placebo.
Clinical Use
Practice impact
- For adults with acute bacterial meningitis, give dexamethasone 10 mg 15 to 20 minutes before or with the first antibiotic, then every 6 hours for four days.
- The pneumococcal signal is a subgroup result and should be labeled as such; the overall primary result already favored dexamethasone.
Applicability
- Most applicable to adults with acute bacterial meningitis in whom dexamethasone can be started before or with the first antibiotic dose.
Limitations
- The pneumococcal comparison is a subgroup analysis by causative organism.
- The abstract does not report organism-specific results for pathogens other than pneumococcus.
- Baseline characteristics were similar, but the abstract does not describe the antibiotic regimen used with dexamethasone.
Common misinterpretations
- The pneumococcal subgroup is supportive, not the primary analysis.
- The trial tested dexamethasone started before or with the first antibiotic; it does not tell you what to do if the first dose was already given hours earlier.
Citation
de Gans J, van de Beek D, European Dexamethasone in Adulthood Bacterial Meningitis Study Investigators. Dexamethasone in adults with bacterial meningitis. N Engl J Med. 2002;347(20):1549-1556. doi:10.1056/NEJMoa021334
Early treatment with dexamethasone improves the outcome in adults with acute bacterial meningitis and does not increase the risk of gastrointestinal bleeding.
- PMID
- 12432041