An Open Label Study of Severe Sepsis in Adults

• Status: Completed
• Trial end date: 2003-10-01
• Target enrollment: 0
• Participant gender: All

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).

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

Details

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

Criteria

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