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NCT00568893 Clinical Trial

An Open Label Study of Severe Sepsis in Adults

Severe Sepsis Clinical Trial

Official title:
An Open Label Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis and Multiple Organ Dysfunctions A Phase IV Protocol

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00568893
Other study ID # 7159
Secondary ID F1K-BX-S001
Status Completed
Phase Phase 4
First received December 5, 2007
Last updated December 5, 2007
Start date January 2003
Est. completion date October 2003

Study information
Verified date December 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority Belgium: Ministry of Social Affairs, Public Health and the Environment
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date October 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• drotrecogin alfa (activated)

Locations
Country Name City State
Belgium 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. Antwerpen
Belgium 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. Arlon
Belgium 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. Bonheiden
Belgium 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. Brugge
Belgium 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. Brussels
Belgium 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. Gent
Belgium 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. Haine-St. Paul
Belgium 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. Hasselt
Belgium 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. Huy
Belgium 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. La Louviere
Belgium 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. Leuven
Belgium 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. Liege
Belgium 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. Mons
Belgium 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. Montigny Le Tilleul
Belgium 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. Ottignies
Belgium 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. Roeselare
Belgium 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. Verviers
Belgium 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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety Data 9 Months
Secondary All cause mortality data. 9 Months
Secondary 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
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