CAPE COD

Among patients with severe community acquired pneumonia requiring ICU or intermediate care unit admission, does hydrocortisone reduce the risk of all-cause mortality at 28 days when compared to placebo?

Study design

Multicenter, double-blind, parallel-group, randomized, controlled trial

Population

Number of patients studied: 795
Inclusion criteria: Aged ≥18 years, admitted to intensive care or intermediate care unit, diagnosis of community-acquired pneumonia within the first 48 hours of admission, study medication initiated within 24 hours after first severity criteria, severe disease with at least one severity criteria, on antibiotics, informed consent
Exclusion criteria: Septic shock treated with vasopressors, aspiration as likely etiology, invasive ventilation in 2 weeks prior to admission, on antibiotics treating a respiratory infection for >7 days at the time of admission, certain pre-existing conditions, flu positive on PCR test, certain viral infections, myelosuppression, DNR, hypersensitivity to corticosteroids, needs corticosteroids or hydrocortisone for other reasons, on prednisone ≥15 mg/day or equivalent dosing of other corticosteroids for >30 days, enrolled in another trial with mortality as an endpoint, pregnant/breastfeeding, under guardianship

Interventions

Experimental group: Hydrocortisone - 200 mg IV per day as a continuous infusion for 4-7 days, followed by a taper
Control group: Placebo

Primary outcome

Significant difference

Secondary outcomes

All-cause mortality at 90 days, ventilation at 28 days, vasopressors at 28 days among those not receiving vasopressors at enrollment

Safety outcomes or Adverse Events

Serious adverse events: 70 events in the hydrocortisone group vs. 99 events in the placebo group

Conclusion

Hydrocortisone benefited severely ill pneumonia patients requiring ICU level care that did not have a contraindication to steroids, though this study excluded those who presented in septic shock requiring vasopressors. Consider hydrocortisone for admitted patients boarding in the ED who meet these inclusion criteri