The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death
NCT ID: NCT00568737
Last Updated: 2007-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2640 participants
INTERVENTIONAL
2002-11-30
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
24 microgram/kg/hr for 96 hours (+ or - 1 hour)
Drotrecogin alfa (activated)
Drotrecogin Alfa (activated)
2
0.9% sodium chloride
Placebo
0.9% sodium chloride
Interventions
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Drotrecogin alfa (activated)
Drotrecogin Alfa (activated)
Placebo
0.9% sodium chloride
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
* Platelet count less than 30,000/mm3.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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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Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
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Córdoba, Córdoba Province, Argentina
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Buenos Aires, , Argentina
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Garran, Australian Capital Territory, Australia
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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
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Hobart, Tasmania, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Prahan, Victoria, Australia
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Nedlands, Western Australia, Australia
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Innsbruck, Innsbuck, Austria
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Wein, Wein, Austria
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Arlon, Arlon, Belgium
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Brussels, Brussels Capital, Belgium
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Ghent, Gent, Belgium
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Liège, Liege, Belgium
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Ottignies, Ottignies, Belgium
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Curitiba, Paraná, Brazil
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Porto Algre, Porto Algre, Brazil
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Rio de Janeiro, Rio de Janerio, Brazil
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Salvador, Salvador, Brazil
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Florianópolis, Santa Catarina, Brazil
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Sao Jose Rio Preto, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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New Westminster, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Las Condes, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Brno, Brno, Czechia
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Hradec Králové, Hradec Kralove, Czechia
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Olomouc, Olomouc, Czechia
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Pilsen, Plzen, Czechia
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Prague, Praha 8, Czechia
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Aalborg, Aalborg, Denmark
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Esbjerg, Esbjerg, Denmark
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Holbæk, Holbaek, Denmark
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Hvidovre, Hvidovre, Denmark
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Roskilde, Roskilde, Denmark
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Sønderborg, Sonderborg, Denmark
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Copenhagen, S, Denmark
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Viborg, Viborg, Denmark
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Cairo, Cairo Governorate, Egypt
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Helsinki, Hus, Finland
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Jyväskylä, Jyvaskyla, Finland
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Kuopio, Kuopio, Finland
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Oulu, Oulu, Finland
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Turku, Turku, Finland
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Argenteuil, Argenteuil, France
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Aulnay-sous-Bois, Aulnay-Sous-Bois, France
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Besançon, Besancon, France
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Dijon, Dijon, France
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Gleizé, Gleize, France
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Corbeil-Essonnes, , France
Countries
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References
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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. doi: 10.1186/cc7011. Epub 2008 Sep 11.
Other Identifiers
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F1K-MC-EVCM
Identifier Type: -
Identifier Source: secondary_id
6669
Identifier Type: -
Identifier Source: org_study_id