The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients With Severe Sepsis

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00045760
First received: September 9, 2002
Last updated: July 18, 2006
Last verified: July 2006
  Purpose

Severe sepsis is defined as a systemic inflammatory response syndrome that results from infection and is associated with acute organ dysfunction. It usually results from bacterial infections, but it may occur in response to other pathogens, such as fungi, viruses, and parasites.


Condition Intervention Phase
Sepsis
Drug: Drotrecogin alfa (activated)
Phase 4

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Study Start Date: September 2002
Detailed Description:

Drotrecogin alfa (activated), a recombinant form of human activated protein C, is the first therapeutic intervention shown to reduce all-cause mortality in severe sepsis. In the Phase 3 study (F1K-MC-EVAD; PROWESS), 1690 patients were randomly assigned to receive a 96-hour intravenous infusion of drotrecogin alfa (activated) 24 micrograms/kg/h or placebo (850 patients and 840 patients, respectively). Overall, administration of drotrecogin alfa (activated) yielded a clinically significant reduction in 28-day all-cause mortality: 24.7% of drotrecogin alfa (activated) patients died versus 30.8% of placebo patients (19.4% relative risk reduction; p=0.005; Bernard et al. 2001). The only safety concern noted in the Phase 3 trial was an increased risk of serious bleeding among drotrecogin alfa (activated) patients (3.5% versus 2.0% of placebo patients). The difference between the two treatment groups in the number of patients who experienced a serious bleeding event was due to the greater number of drotrecogin alfa (activated) patients who experienced a serious bleeding event that was related to a procedure (for example, bleeding that resulted from the placement of a catheter or nephrostomy tube). The number of patients who experienced spontaneous serious bleeding events was similar between the two treatment groups.

The Regulatory authorities have approved the use of drotrecogin alfa (activated) in severe sepsis patients with a high level of disease severity and risk of death. Thus, the regulatory authorities have requested a study evaluating drotrecogin alfa (activated) in a specific subpopulation of patients with severe sepsis and at lower risk of death.

  Eligibility

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

Inclusion Criteria:

  • Adult patients with severe sepsis.
  • Presence of a suspected or proven infection.
  • One or more sepsis-associated organ failure.

Exclusion Criteria:

  • Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country.
  • Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
  • Platelet count <30,000/mm3.
  • Are receiving therapeutic heparin.
  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: NCT00045760

  Show 426 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00045760     History of Changes
Other Study ID Numbers: 7252, 6669, F1K-MC-EVCL, F1K-MC-EVCM
Study First Received: September 9, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

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 August 25, 2014