BACKGROUND: Data on the long-term effect of dexamethasone on survival in bacterial meningitis are lacking. METHODS: A long-term follow-up study of the European Dexamethasone in Adulthood Bacterial Meningitis Study was performed. In this double-blind, randomized clinical trial, 301 patients were randomly assigned to receive adjunctive dexamethasone (n = 157) or placebo (n = 144) between June 1993 and December 2001. We obtained survival data of patients using the Dutch Municipal Population Register. RESULTS:Death had occurred in 32 of 301 included patients (11%) at the primary outcome measurement 8 weeks after randomization. Follow-up was obtained for 228 of 246 evaluable patients (93%), with median follow-up of 13 years. Overall, 31 of 144 patients (22%) in the dexamethasone group died and 44 of 134 patients (33%) in the placebo group died (log-rank p = 0.029). After the primary end point of the study at 8 weeks, 20 patients in the dexamethasone group died and 23 patients in the placebo group died (log-rank p = 0.27), with age being the sole predictor of death (p < 0.001). CONCLUSIONS: In adults with community-acquired bacterial meningitis, the survival benefit from adjunctive dexamethasone therapy is obtained in the acute phase of the disease and remains for years. CLASSIFICATION OF EVIDENCE: This study of a population of Dutch patients shows Class III evidence that dexamethasone provides an extended survival benefit in patients treated for bacterial meningitis, and this survival benefit extends as long as 20 years.
RCT Entities:
BACKGROUND: Data on the long-term effect of dexamethasone on survival in bacterial meningitis are lacking. METHODS: A long-term follow-up study of the European Dexamethasone in Adulthood Bacterial Meningitis Study was performed. In this double-blind, randomized clinical trial, 301 patients were randomly assigned to receive adjunctive dexamethasone (n = 157) or placebo (n = 144) between June 1993 and December 2001. We obtained survival data of patients using the Dutch Municipal Population Register. RESULTS:Death had occurred in 32 of 301 included patients (11%) at the primary outcome measurement 8 weeks after randomization. Follow-up was obtained for 228 of 246 evaluable patients (93%), with median follow-up of 13 years. Overall, 31 of 144 patients (22%) in the dexamethasone group died and 44 of 134 patients (33%) in the placebo group died (log-rank p = 0.029). After the primary end point of the study at 8 weeks, 20 patients in the dexamethasone group died and 23 patients in the placebo group died (log-rank p = 0.27), with age being the sole predictor of death (p < 0.001). CONCLUSIONS: In adults with community-acquired bacterial meningitis, the survival benefit from adjunctive dexamethasone therapy is obtained in the acute phase of the disease and remains for years. CLASSIFICATION OF EVIDENCE: This study of a population of Dutch patients shows Class III evidence that dexamethasone provides an extended survival benefit in patients treated for bacterial meningitis, and this survival benefit extends as long as 20 years.
Authors: Aaron M Cook; G Morgan Jones; Gregory W J Hawryluk; Patrick Mailloux; Diane McLaughlin; Alexander Papangelou; Sophie Samuel; Sheri Tokumaru; Chitra Venkatasubramanian; Christopher Zacko; Lara L Zimmermann; Karen Hirsch; Lori Shutter Journal: Neurocrit Care Date: 2020-06 Impact factor: 3.210