Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

• Phase: Phase 3
• 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 evidence of infection

• Must have systemic inflammatory response syndrome (SIRS)

• Must have vasopressor-dependent septic shock

Exclusion Criteria:

• Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug

• Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion

• Have single organ dysfunction and recent surgery (within 30 days of study entry)

• Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period

• Are not expected to survive 28 days given their preexisting uncorrectable medical condition