An Open Label Study of Severe Sepsis in Adults

Eli Lilly and Company130 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Severe Sepsis

Interventions

drotrecogin alfa (activated)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Outcomes

Primary Outcomes

Safety Data

Time frame: 9 Months

Secondary Outcomes

All cause mortality data.

Time frame: 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).

Time frame: 9 Months

Data from ClinicalTrials.gov

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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.

Antwerp, Belgium

Arlon, Belgium

Bonheiden, Belgium

Bruges, Belgium

Brussels, Belgium

Ghent, Belgium

Haine-St. Paul, Belgium

Hasselt, Belgium

Huy, Belgium

La Louvière, Belgium

...and 8 more locations