NCT00568893

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Severe Sepsis

Interventions

Type	Name	Description
DRUG	drotrecogin alfa (activated)

Timeline

• Start date: 2003-01-01
• Completion: 2003-10-01
• First posted: 2007-12-06
• Last updated: 2007-12-06

Locations

18 sites across 1 country: Belgium