An Open Label Study of Severe Sepsis in Adults

Lilly

Status and phase: Completed; Phase 4

Conditions: Severe Sepsis

Treatments: Drug: drotrecogin alfa (activated)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00568893

7159

F1K-BX-S001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

1

Experimental group

Description:

24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Treatment:

Drug: drotrecogin alfa (activated)