The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00568737
First received: December 5, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

Adult Patients with Severe Sepsis


Condition Intervention Phase
Sepsis
Drug: Drotrecogin alfa (activated)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 20 months ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 20 months ]

Enrollment: 2640
Study Start Date: November 2002
Study Completion Date: February 2005
Arms Assigned Interventions
Experimental: 1
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
Drug: Drotrecogin alfa (activated)
Drotrecogin Alfa (activated)
Other Names:
  • LY203638
  • Xigris
Placebo Comparator: 2
0.9% sodium chloride
Drug: Placebo
0.9% sodium chloride

Detailed Description:

Compared with placebo, drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with severe sepsis at low risk of death (for example, with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score <25 or single organ dysfunction).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.

Exclusion Criteria:

  • Are indicated for the treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
  • Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
  • Platelet count less than 30,000/mm3.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00568737

  Show 71 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00568737     History of Changes
Other Study ID Numbers: 6669, F1K-MC-EVCM
Study First Received: December 5, 2007
Last Updated: December 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Severe Sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Drotrecogin alfa activated
Protein C
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014