The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients With Severe Sepsis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Severe sepsis is defined as a systemic inflammatory response syndrome that results from infection and is associated with acute organ dysfunction. It usually results from bacterial infections, but it may occur in response to other pathogens, such as fungi, viruses, and parasites.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Drotrecogin alfa activated; Protein C

Criteria

Inclusion Criteria:

• Adult patients with severe sepsis.

• Presence of a suspected or proven infection.

• One or more sepsis-associated organ failure.

Exclusion Criteria:

• Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country.

• Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.

• Platelet count <30,000/mm3.

• Are receiving therapeutic heparin.