European Dexamethasone Study
Trial question
What is the role of dexamethasone in adults with bacterial meningitis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
44.0% female
56.0% male
N = 301
301 patients (132 female, 169 male)
Inclusion criteria: adult patients with bacterial meningitis
Key exclusion criteria: history of hypersensitivity to β-lactam antibiotics or corticosteroids; pregnancy; treatment with oral or parenteral antibiotics in the previous 48 hours, history of active tuberculosis or fungal infection, or a recent history of head trauma, neurosurgery, or peptic ulcer disease
Interventions
N=157 dexamethasone (10 mg administered 15 to 20 minutes before or with the first dose of antibiotic and was given every 6 hours for four days)
N=144 placebo (matching placebo)
Primary outcome
Unfavorable outcome
15
25
25.0 %
18.8 %
12.5 %
6.3 %
0.0 %
Dexamethasone
Placebo
Significant
decrease ▼
NNT = 10
Significant decrease in unfavorable outcome (15% vs. 25%; RR 0.59, 95% CI 0.37 to 0.94)
Secondary outcomes
Significant decrease in death (7% vs. 15%; RR 0.48, 95% CI 0.24 to 0.96)
Significant decrease in unfavorable outcomes (26% vs. 52%; RR 0.5, 95% CI 0.3 to 0.83)
Safety outcomes
No significant differences in gastrointestinal bleeding (1% vs. 3%, p=0.27).
Conclusion
In adult patients with bacterial meningitis, dexamethasone was superior to placebo with respect to unfavorable outcome.
Reference
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 Nov 14;347(20):1549-56.
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