ESCAPe (community-acquired pneumonia)
Trial question
What is the role of prolonged low-dose methylprednisolone in patients with severe community-acquired pneumonia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
4.0% female
96.0% male
N = 584
584 patients (22 female, 562 male)
Inclusion criteria: adult patients with severe community-acquired pneumonia presenting in hospital within 72-96 hours
Key exclusion criteria: vasopressor-dependent shock requiring multiple or high-dose vasopressors; major gastrointestinal bleeding; postoperative pneumonia; cystic fibrosis; active tuberculosis; fungal infection
Interventions
N=297 methylprednisolone (intravenous 40 mg loading bolus, followed by 40 mg/day through day 7 and progressive tapering during the 20-day treatment course)
N=287 placebo (matching placebo for 20 days)
Primary outcome
Death from all causes at day 60
16
18
18.0 %
13.5 %
9.0 %
4.5 %
0.0 %
Methylprednisolone
Placebo
No significant
difference ↔
No significant difference in death from all causes at day 60 (16% vs. 18%; aOR 0.9, 95% CI 0.57 to 1.4)
Secondary outcomes
No significant difference in vasopressor-dependent shock development in hospital (5% vs. 4%; )
No significant difference in acute lung injury-ARDS development in hospital (4% vs. 3%; )
No significant difference in death in the hospital (12% vs. 10%; AD 2%, 95% CI -3 to 7)
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In adult patients with severe community-acquired pneumonia presenting in hospital within 72-96 hours, methylprednisolone was not superior to placebo with respect to death from all causes at day 60.
Reference
G Umberto Meduri, Mei-Chiung Shih, Lisa Bridges et al. Low-dose methylprednisolone treatment in critically ill patients with severe community-acquired pneumonia. Intensive Care Med. 2022 Aug;48(8):1009-102.
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