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
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
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.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35294, United States
Loma Linda, California 92350, United States
Long Beach, California 90806, United States
San Diego, California 92123, United States
Colorado Springs, Colorado 80920, United States
Denver, Colorado 80204, United States
Idaho Falls, Idaho 83404, United States
Chicago, Illinois 60611, United States
Iowa City, Iowa 52242, United States
Topeka, Kansas 66604, United States
Hazard, Kentucky 41701, United States
Lansing, Michigan 48912, United States
Chesterfield, Missouri 63017, United States
St Louis, Missouri 63131, United States
Missoula, Montana 59802, United States
Brooklyn, New York 11215, United States
Staten Island, New York 10305, United States
Greensboro, North Carolina 27403, United States
Portland, Oregon 97239, United States
Philadelphia, Pennsylvania 19107, United States
Pittsburgh, Pennsylvania 15240, United States
San Antonio, Texas 78229, United States
Norfolk, Virginia 23507, United States
Garran, Australian Capital Territory 2605, Australia
Newcastle, New South Wales 2305, Australia
St Leonards, New South Wales 2065, Australia
Herston, Queensland 4029, Australia
Adelaide, South Australia 5000, Australia
Box Hill, Victoria 3128, Australia
Epping, Victoria 3076, Australia
Heidelberg, Victoria 3084, Australia
Melbourne, Victoria 3004, Australia
Parkville, Victoria 3050, Australia
Antwerp, 2020, Belgium
Antwerp, 2060, Belgium
Brussels, 1200, Belgium
Edegem, 2650, Belgium
Genk, 3600, Belgium
Leuven, 3000, Belgium
Liège, 4000, Belgium
Ottignies, 1340, Belgium
Roeselare, 8800, Belgium
Wilrijk, 2610, Belgium
Yvoir, 5530, Belgium
Belo Horizonte, 30140-093, Brazil
Joinville, 89202-050, Brazil
Londrina, 86038, Brazil
Porto Alegre, 90610-970, Brazil
Sao Jose Rio Preto, 15090, Brazil
São Paulo, 05403-000, Brazil
Calgary, Alberta T2N 2T9, Canada
Vancouver, British Columbia V5Z 1M9, Canada
Winnipeg, Manitoba R3A 1R9, Canada
Thunder Bay, Ontario P7B 6V4, Canada
Toronto, Ontario M4N 3M5, Canada
Montreal, Quebec H4J 1C5, Canada
Sherbrook, Quebec J1H 5N4, Canada
Brno, 656 91, Czechia
Hradec Králové, 500 05, Czechia
Olomouc, 775 20, Czechia
Pilsen, 304 60, Czechia
Prague, 128 08, Czechia
Ústà nad Labem, 40113, Czechia
Helsinki, 00029, Finland
Jyväskylä, 40620, Finland
Kuopio, 70211, Finland
Lahti, 15850, Finland
Seinäjoki, 60220, Finland
Tampere, 33520, Finland
Angers, 49933, France
Argenteuil, 95107, France
Bobigny, 93009, France
Bordeaux, 33076, France
Dijon, 21079, France
La Roche-sur-Yon, 85000, France
Le Kremlin-Bicêtre, 94275, France
Limoges, 87042, France
Lyon, 69437, France
Montpellier, 34295, France
Nantes, 44093, France
Nice, 06202, France
Nîmes, 30029, France
Paris, 75010, France
Poissy, 78300, France
Poitiers, 86021, France
Pringy, 74370, France
Rennes, 35033, France
Saint-Etienne, 42055, France
Saint-Michel, 16 470, France
Toulon, 83056, France
Tours, 37044, France
Vandœuvre-lès-Nancy, 54500, France
Aachen, 52074, Germany
Augsburg, 86156, Germany
Berlin, 13125, Germany
Göttingen, 37075, Germany
Hamburg, 20246, Germany
Heidelberg, 69120, Germany
Kiel, 24105, Germany
Munich, 81377, Germany
Bangalore, 560 002, India
New Delhi, 110 025, India
Pune, 411004, India
Catania, 95124, Italy
Florence, 50143, Italy
Milan, 20132, Italy
Monza, 20052, Italy
Novara, 28100, Italy
Padova, 35127, Italy
Rome, 00168, Italy
Torino, 10126, Italy
Varese, 21100, Italy
Mexico City, 07760, Mexico
Tlalpan, 14000, Mexico
Arnhem, 6815 AD, Netherlands
Ede, 6716 RP, Netherlands
Nijmegen, 8525 GA, Netherlands
Auckland, 1640, New Zealand
Christchurch, 8011, New Zealand
Grafton, 1023, New Zealand
Hamilton, 3204, New Zealand
Wellington, 6022, New Zealand
Lisbon, 1449-005, Portugal
Porto, 4202-451, Portugal
Alcalá de Henares, 28805, Spain
Barcelona, 08035, Spain
Burgos, 9005, Spain
Getafe, 28905, Spain
Las Palmas, 35010, Spain
Madrid, 28040, Spain
Murcia, 30008, Spain
Palma de Mallorca, 7010, Spain
Sabadell, 8208, Spain
Seville, 41007, Spain
Tortosa, 43500, Spain
Valladolid, 47012, Spain
Lugano, CH-69100, Switzerland
Sankt Gallen, CH-9007, Switzerland
Zurich, CH-8091, Switzerland
Bristol, Avon BS2 8HW, United Kingdom
Plymouth, Devon PL6 8DH, United Kingdom
Chelmsford, Essex CM2 5ET, United Kingdom
Portsmouth, Hampshire P06 3LY, United Kingdom
Southampton, Hants SO16 6YD, United Kingdom
Edinburgh, Scotland EH4 2XU, United Kingdom
Glasgow, Scotland G42 9TY, United Kingdom
Guildford, Surrey GU2 7XX, United Kingdom
Birmingham, West Midlands B15 2TH, United Kingdom
Chichester, West Sussex PO19 6SE, United Kingdom