An Open Label Study of Severe Sepsis in Adults

Phase 4

Completed

• Conditions: Severe Sepsis
• Interventions: Drug: drotrecogin alfa (activated)

• Registration Number: NCT00568893
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Study Timeline

• Study Start: 2003-01
• Study Completion: 2003-10
• Status Verified: 2007-12
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Last Update Submitted: 2007-12-05
• Study First Posted: 2007-12-06
• Last Update Posted: 2007-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	drotrecogin alfa (activated)	24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Primary Outcome Measures

Name	Time	Method
Safety Data	9 Months

Secondary Outcome Measures

Name	Time	Method
All cause mortality data.	9 Months
To determine the final disposition of sepsis patients treated with drotrecogin alfa (activated)(that is, patient location at discharge from study hospital or 90 days).	9 Months

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇧🇪 Wilrijk, Belgium