Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion

A Phase IIIb Study to Determine Efficacy and Safety of Extended Drotrecogin Alfa (Activated) Therapy in Patients With Persistent Requirement for Vasopressor Support After 96 Hour Infusion With Commercial Drotrecogin Alfa (Activated)

The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.

Inclusion Criteria:

• Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
• Continue requirement of Vasopressor support after 96 hour commercial infusion

Exclusion Criteria:

• Patients require extensive surgical procedures within next 3 days
• Patients with platelet count below 30,000/mm3
• Patients receiving therapeutic heparin of 15,000 units/day and more
• Patients not expected to survive 24 days
• Patients contraindicated as to the country specific registration