CAPE COD
Trial question
What is the role of hydrocortisone in severe community-acquired pneumonia?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 795
795 patients (243 female, 552 male).
Inclusion criteria: adult patients who had been admitted to the ICU for severe community-acquired pneumonia.
Key exclusion criteria: DNI order; pneumonia caused by influenza; and septic shock.
Interventions
N=400 hydrocortisone (200 mg daily for either 4 or 8 days as determined by clinical improvement, followed by tapering for a total of 8 or 14 days).
N=395 placebo (matching placebo).
Primary outcome
Death at day 28
6.2%
11.9%
11.9 %
8.9 %
6.0 %
3.0 %
0.0 %
Hydrocortisone
Placebo
Significant
decrease ▼
NNT = 17
Significant decrease in death at day 28 (6.2% vs. 11.9%; ARD -5.6, 95% CI -9.6 to -1.7).
Secondary outcomes
Significant decrease in the rate of endotracheal intubation by day 28 in patients not undergoing mechanical ventilation at baseline (18% vs. 29.5%; HR 0.59, 95% CI 0.4 to 0.86).
Significant decrease in the rate of endotracheal intubation by day 28 in patients not receiving endotracheal intubation at baseline (19.5% vs. 27.7%; HR 0.69, 95% CI 0.5 to 0.94).
Significant decrease in the rate of vasopressors initiation by day 28 in patients not receiving vasopressor at baseline (15.3% vs. 25%; HR 0.59, 95% CI 0.43 to 0.82).
Safety outcomes
No significant differences in hospital-acquired infection, gastrointestinal bleeding, weight change.
Significant difference in median daily dose of insulin by day 7 in patients receiving insulin therapy (35.5 IU/day vs. 20.5 IU/day).
Conclusion
In adult patients who had been admitted to the ICU for severe community-acquired pneumonia, hydrocortisone was superior to placebo with respect to death at day 28.
Reference
Pierre-François Dequin, Ferhat Meziani, Jean-Pierre Quenot et al. Hydrocortisone in Severe Community-Acquired Pneumonia. N Engl J Med. 2023 May 25;388(21):1931-1941.
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