- Prospective, randomized, double-blinded, placebo-controlled multicenter
trial conducted in European countries (Netherlands, Belgium, Germany,
Denmark, Austria) from June 1993 through December 2001.
- 301 patients were randomly assigned to a treatment group: 157 received
dexamethasone and 144 received placebo. Analysis was by intention-to-treat.
- Patients received 10 mg of dexamethasone or placebo, given 15 to
20 minutes before or with the first dose of antibiotic, and continued
every 6 hours for 4 days.
- Inclusion criteria: age 17 or older;clinical suspicion of meningitis;at
least one of: cloudy CSF, +bacteria on Gram stain, CSF WBC count >1000/mm3.
- Exclusion criteria: hypersensitivity to beta-lactam antibiotics or
corticosteroids; pregnant; CSF shunt; antibiotic treatment in previous
48 hours; history of active TB or fungal infection; recent head trauma,
neurosurgery, or peptic ulcer disease; participating in another trial.
- Primary outcome measure: Glasgow Outcome Scale, a measure of independent
functional status, at 8 weeks from initial randomization. Secondary
outcomes: death, focal neurologic abnormalities (aphasia, cranial nerve
palsy, monoparesis, hemiparesis, severe ataxia), hearing loss, GI bleeding,
fungal infections, hyperglycemia.
- Subgroup analysis, according to causative organism (S. pneumoniae,
N. meningitidis, other bacteria, negative cultures), was performed.
- Treatment with dexamethasone was associated with a reduction in the
risk of an unfavorable outcome (RR 0.59; P = 0.03). Treatment with dexamethasone
was also associated with a reduction in mortality (RR 0.48; P = 0.04).
- Dexamethasone was not associated with increased risk for adverse