What is the treatment regimen for the Cape Cod trial?

CAPE COD Trial Treatment Regimen

The CAPE COD trial treatment regimen consists of intravenous hydrocortisone at 200 mg daily for either 4 or 7 days (determined by clinical improvement), followed by tapering for a total of 8 or 14 days, in addition to standard therapy including antibiotics and supportive care. 1

Treatment Protocol Details

• Intravenous hydrocortisone is administered at a dose of 200 mg daily 1
• Duration of full-dose treatment is either 4 or 7 days, depending on clinical improvement 1
• Following the initial treatment period, hydrocortisone is tapered over time for a total treatment duration of either 8 or 14 days 1
• All patients receive standard therapy, including appropriate antibiotics and supportive care alongside the hydrocortisone regimen 1

Clinical Context and Population

• The CAPE COD trial was a phase 3, multicenter, double-blind, randomized controlled trial 1
• The study specifically targeted adults admitted to the intensive care unit (ICU) with severe community-acquired pneumonia 1
• The trial was stopped early after the second planned interim analysis due to clear evidence of benefit 1

Outcomes and Benefits

• The primary outcome was death at 28 days, which occurred in 6.2% of patients in the hydrocortisone group versus 11.9% in the placebo group (absolute difference of -5.6 percentage points) 1
• Among patients not undergoing mechanical ventilation at baseline, endotracheal intubation was required in 18.0% of the hydrocortisone group versus 29.5% in the placebo group 1
• Among patients not receiving vasopressors at baseline, such therapy was initiated by day 28 in 15.3% of the hydrocortisone group versus 25.0% in the placebo group 1

Safety Considerations

• The frequencies of hospital-acquired infections and gastrointestinal bleeding were similar between the hydrocortisone and placebo groups 1
• Patients in the hydrocortisone group required higher daily doses of insulin during the first week of treatment 1
• The trial demonstrated that the hydrocortisone regimen had an acceptable safety profile in this critically ill population 1

Clinical Implementation

• The CAPE COD trial provides high-quality evidence for using hydrocortisone in severe community-acquired pneumonia requiring ICU admission 1
• The treatment protocol should be implemented as described in the trial to achieve similar outcomes 1
• Monitoring for hyperglycemia requiring insulin adjustment is important during the treatment period 1