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

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ClinicalTrials.gov Identifier: NCT00568737
Recruitment Status : Completed
First Posted : December 6, 2007
Last Update Posted : December 6, 2007
Sponsor:
Information provided by:
Eli Lilly and Company

Brief Summary:
Adult Patients with Severe Sepsis

Condition or disease Intervention/treatment Phase
Sepsis Drug: Drotrecogin alfa (activated) Drug: Placebo Phase 3

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis
Study Start Date : November 2002
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Efficacy [ Time Frame: 20 months ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 20 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568737


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Locations
Argentina
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Haedi, Buenos Aires, Argentina
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Monte Grande, Buenos Aires, Argentina
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Rosario - Santa Fe, Buenos Aires, Argentina
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Buenos Aires, Argentina
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Ciudad De Buenos Aires, Argentina
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Cordoba, Argentina
Australia, Australian Capital Territory
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Garran, Australian Capital Territory, Australia
Australia, New South Wales
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Camperdown, New South Wales, Australia
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Kingswood, New South Wales, Australia
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Randwick, New South Wales, Australia
Australia, Tasmania
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Hobart, Tasmania, Australia
Australia, Victoria
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Prahan, Victoria, Australia
Australia, Western Australia
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Nedlands, Western Australia, Australia
Austria
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Innsbruck, Innsbuck, Austria
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Wein, Austria
Belgium
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Arlon, Belgium
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Brussels, Belgium
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Bruxelles, Belgium
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Gent, Belgium
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Liege, Belgium
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Ottignies, Belgium
Brazil
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Curitiba, PR, Brazil
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Rio de Janeiro, Rio De Janerio, Brazil
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Sao Jose Rio Preto, Sao Paulo, Brazil
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Florianopolis, SC, Brazil
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Porto Algre, Brazil
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Salvador, Brazil
Canada, Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
Canada, British Columbia
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New Westminister, British Columbia, Canada
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Vancouver, British Columbia, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Brampton, Ontario, Canada
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Sudbury, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
Canada, Quebec
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Greenfield Park, Quebec, Canada
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Sherbrooke, Quebec, Canada
Canada, Saskatchewan
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
Chile
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Las Condes, Santiago, Chile
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Santiago, Chile
Czech Republic
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Brno, Czech Republic
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Hradec Kralove, Czech Republic
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Olomouc, Czech Republic
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Plzen, Czech Republic
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Praha 8, Czech Republic
Denmark
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Copenhagen, S, Denmark
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Aalborg, Denmark
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Esbjerg, Denmark
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Holbaek, Denmark
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Hvidovre, Denmark
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Roskilde, Denmark
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Sonderborg, Denmark
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Viborg, Denmark
Egypt
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Cairo, Egypt
Finland
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Helsinki, Hus, Finland
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Jyvaskyla, Finland
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Kuopio, Finland
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Oulu, Finland
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Turku, Finland
France
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Argenteuil, France
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Aulnay-Sous-Bois, France
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Besancon, France
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Corbeil Essonnes, France
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Dijon, France
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Gleize, France
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

Additional Information:
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
First Posted: December 6, 2007    Key Record Dates
Last Update Posted: December 6, 2007
Last Verified: December 2007

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
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action