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Sponsored by: |
Eli Lilly and Company |
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Information provided by: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT00568737 |
Adult Patients with Severe Sepsis
Condition | Intervention | Phase |
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Sepsis |
Drug: Drotrecogin alfa (activated) Drug: Placebo |
Phase III |
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 |
Enrollment: | 2640 |
Study Start Date: | November 2002 |
Study Completion Date: | February 2005 |
Arms | Assigned Interventions |
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1: Experimental
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
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Drug: Drotrecogin alfa (activated)
Drotrecogin Alfa (activated)
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2: Placebo Comparator
0.9% sodium chloride
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Drug: Placebo
0.9% sodium chloride
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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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Severe Sepsis |
Systemic Inflammatory Response Syndrome Drotrecogin alfa activated Death |
Sepsis Protein C Inflammation |
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 |