Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.

Note: The protocol was amended to remove the option of shorter infusion durations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Must be 18 years or older

• Must have a suspected or proven infection

• Must have two or more sepsis-associated organ dysfunctions

Exclusion Criteria:

• Documented multiple organ dysfunction greater than 24 hours prior to start of study drug

• Actual body weight less than 30 kg or more than 135 kg

• Platelet count less than 30,000/mm^3

• Active internal bleeding or at increased risk of bleeding

• Not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition