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An Open Label Study of Severe Sepsis in Adults

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00568893
First received: December 5, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 5, 2007
December 5, 2007
January 2003
Not Provided
Safety Data [ Time Frame: 9 Months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
An Open Label Study of Severe Sepsis in Adults
An Open Label Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis and Multiple Organ Dysfunctions A Phase IV Protocol

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.

Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Severe Sepsis
Drug: drotrecogin alfa (activated)
Other Names:
  • LY203638
  • Xigris
Experimental: 1
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
Intervention: Drug: drotrecogin alfa (activated)
Hodder RV, Hall R, Russell JA, Fisher HN, Lee B. Early drotrecogin alpha (activated) administration in severe sepsis is associated with lower mortality: a retrospective analysis of the Canadian ENHANCE cohort. Crit Care. 2009;13(3):R78. Epub 2009 May 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
October 2003
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00568893
7159, F1K-BX-S001
No
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP