An Open Label Study of Severe Sepsis in Adults

An Open Label Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis and Multiple Organ Dysfunctions A Phase IV Protocol

This trial is to obtain safety data in adult patients with severe sepsis and two sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).

To collect safety data while providing drotrecogin alfa (activated) for the treatment of patients with severe sepsis with multiple organ dysfunctions. Patient access to drotrecogin alfa (activated) will be provided under this protocol prior to and during its review by the Authorities of Belgium and Luxemburg for commercial release.

Inclusion Criteria:

• Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria:

  1. Must be 18 years.
  2. Suspected or proven infection
  3. Have or have had two or more sepsis-induced organ failures sepsis

Exclusion Criteria:

• Patients will be excluded from entry in this study for any of the following reasons:

  1. Documented first organ dysfunction greater than 48-hours prior to start of study drug.
  2. Patients greater than 135 kg in weight.
  3. Patients with a platelet count less than 30,000/mm3
  4. Active internal bleeding or at increased risk for bleeding