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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014