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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00568737

Purpose

Adult Patients with Severe Sepsis

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), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis

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
1: Experimental 24 microgram/kg/hr for 96 hours (+ or - 1 hour)	Drug: Drotrecogin alfa (activated) Drotrecogin Alfa (activated)
2: Placebo Comparator 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

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

Publications indexed to this study:

Laterre PF, Macias WL, Janes J, Williams MD, Nelson DR, Girbes AR, Dhainaut JF, Abraham E. Influence of enrollment sequence effect on observed outcomes in the ADDRESS and PROWESS studies of drotrecogin alfa (activated) in patients with severe sepsis. Crit Care. 2008;12(5):R117. Epub 2008 Sep 11.

Study ID Numbers:	6669, F1K-MC-EVCM
Study First Received:	December 5, 2007
Last Updated:	December 5, 2007
ClinicalTrials.gov Identifier:	NCT00568737
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Severe Sepsis

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome
Drotrecogin alfa activated
Death

Sepsis
Protein C
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 15, 2009