Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00604214

Purpose

The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

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

MedlinePlus related topics: Sepsis

Drug Information available for: Sodium chloride Chlorides Drotrecogin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Treatment with drotrecogin alfa (activated)compared with placebo reduces 28-day mortality in adult patients with septic shock [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To demonstrate that treatment with drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with septic shock and severe protein C deficiency compared with placebo. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Treatment with drotrecogin alfa (activated) improves cardiovascular, respiratory, and renal organ function compared with placebo. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Drotrecogin alfa (activated) has an acceptable safety profile in this patient population. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1500
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Drotrecogin alfa (activated) 24 mcg/kg/hr, IV, 96hr
2: Placebo Comparator	Drug: Placebo 0.9% sodium chloride, IV, 96 hrs

Eligibility

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

Criteria

Inclusion Criteria:

Must be 18 years or older
Must have evidence of infection
Must have systemic inflammatory response syndrome(SIRS)
Must have vasopressor-dependent septic shock

Exclusion Criteria:

Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug
Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion
Have single organ dysfunction and recent surgery (within 30 days of study entry)
Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period
Are not expected to survive 28 days given their preexisting uncorrectable medical condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604214

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

Show 181 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

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11940, F1K-MC-EVDP
Study First Received:	January 24, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00604214
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Sepsis
Septic shock

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Drotrecogin alfa activated
Sepsis
Protein C

Shock
Shock, Septic
Inflammation

Additional relevant MeSH terms:

Anti-Infective Agents
Fibrin Modulating Agents
Anticoagulants
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Fibrinolytic Agents
Cardiovascular Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009