ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
July 21, 2017 updated by: Eisai Inc.
The purpose of this study is to compare eritoran tetrasodium and placebo in patients with severe sepsis and to demonstrate a reduction of mortality from all causes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2000
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina
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Cordoba, Argentina
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Santa Fe, Argentina
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Box Hill, Australia
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New South Wales, Australia
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Queensland, Australia
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New South Wales
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St. Leonards, New South Wales, Australia
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Westmead, New South Wales, Australia
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Queensland
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Southport, Queensland, Australia
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South Australia
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Adelaide, South Australia, Australia
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Woodville, South Australia, Australia
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Victoria
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Heidelberg, Victoria, Australia
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Melbourne, Victoria, Australia
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Parkville, Victoria, Australia
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Western Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Salzburg, Austria
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Wien, Austria
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Braine-l'Alleud, Belgium
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Brussels, Belgium
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Gent, Belgium
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Liege, Belgium
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Mons, Belgium
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Ottignies, Belgium
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Seraing, Belgium
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Yvoir, Belgium
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Belo Horizonte, Brazil
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Curitba, Brazil
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Fontaleza, Brazil
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Joinville, Brazil
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Porto Alegro, Brazil
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Rio de Janeiro, Brazil
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Sao Paulo, Brazil
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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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British Columbia
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Manitoba
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Winnipeg, Manitoba, Canada
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New Brunswick
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Saint John, New Brunswick, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Quebec
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Quebec City, Quebec, Canada
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Santiago, Chile
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Temuco, Chile
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Valdivia, Chile
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Vina del Mar, Chile
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Brno, Czechia
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Havlickuv Brod, Czechia
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Hradec Kralove, Czechia
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Plyzen, Czechia
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Praha, Czechia
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Amiens, France
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Besancon, France
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Colombes, France
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Corbeil Essonnes, France
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Evry Courcouronnes, France
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La Roche sur Yon, France
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La Tronche, France
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Le Chesnay, France
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Limoges, France
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Montauban, France
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Nimes, France
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Paris, France
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Saint-Michel, France
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Tours, France
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Aachen, Germany
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Berlin, Germany
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Bonn, Germany
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Erfurt, Germany
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Erlangen, Germany
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Frankfurt, Germany
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Geissen, Germany
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Hannover, Germany
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Jena, Germany
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Koln, Germany
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Krefeld, Germany
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Ludwigshafen, Germany
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Munchen, Germany
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Hong Kong, Hong Kong
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Afula, Israel
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Hadera, Israel
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Haifa, Israel
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Holon, Israel
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Jerusalem, Israel
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Kfar Saba, Israel
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Nahariya, Israel
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Petah-Tikva, Israel
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Tel Hashomer, Israel
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Zerifin, Israel
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Bari, Italy
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Busto Arsizio, Italy
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Cesana, Italy
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Milan, Italy
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Monza, Italy
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Novara, Italy
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Pavia, Italy
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Trieste, Italy
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Verona, Italy
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Aichi, Japan
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Bunkyo, Japan
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Chuo, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Hachioji, Japan
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Hamamatsu, Japan
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Hirosaki City, Japan
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Hiroshima, Japan
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Iizuka, Japan
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Itabashi, Japan
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Kagoshima, Japan
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Kamagaya, Japan
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Kanagawa, Japan
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Kishiwada, Japan
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Kobe, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Morioka, Japan
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Osaka, Japan
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Saga, Japan
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Sapporo, Japan
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Sendai, Japan
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Shinagawa, Japan
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Suita, Japan
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Ube, Japan
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Utsunomiya, Japan
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Yonago, Japan
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Yotsukaidou, Japan
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Seoul, Korea, Republic of
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Amsterdam, Netherlands
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Apeldoorn, Netherlands
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Ede, Netherlands
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Groningen, Netherlands
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Leeuwarden, Netherlands
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Rotterdam, Netherlands
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Tilburg, Netherlands
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Utrecht, Netherlands
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Zwolle, Netherlands
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s'Hertogenbosch, Netherlands
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Bielsko Biala, Poland
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Groszisk Mazowiecki, Poland
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Krakow, Poland
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Lodz, Poland
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Poznan, Poland
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Warsaw, Poland
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Almada, Portugal
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Amadora, Portugal
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Lisbon, Portugal
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Alberton, South Africa
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Cape Town, South Africa
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Centurion, South Africa
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Johannesburg, South Africa
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Kimberley, South Africa
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Parow, South Africa
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Pietermaritzburg, South Africa
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Roodepoort, South Africa
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Alcala de Henares Madrid, Spain
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Barcelona, Spain
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Burgos, Spain
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Cataluna, Spain
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Getafe, Spain
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Madrid, Spain
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Sabadell, Spain
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Santiago de Compostela, Spain
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Tarragona, Spain
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Bern, Switzerland
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Geneva, Switzerland
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Lausanne, Switzerland
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Yung Kang City, Taiwan
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Birmingham, United Kingdom
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Leeds, United Kingdom
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Livingston, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Southampton, United Kingdom
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Alabama
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Arizona
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Mesa, Arizona, United States
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California
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Loma Linda, California, United States
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Marysville, California, United States
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Orange, California, United States
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San Diego, California, United States
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Santa Barbara, California, United States
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Colorado
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Denver, Colorado, United States
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Connecticut
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New Haven, Connecticut, United States
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Delaware
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Newark, Delaware, United States
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District of Columbia
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Washington, D.C., District of Columbia, United States
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Florida
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Atlantis, Florida, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Pensacola, Florida, United States
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Georgia
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Idaho
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Idaho Falls, Idaho, United States
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Illinois
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Chicago, Illinois, United States
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Oak Park, Illinois, United States
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Peoria, Illinois, United States
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Indiana
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Indianapolis, Indiana, United States
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Iowa
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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Kansas
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Kansas City, Kansas, United States
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Topeka, Kansas, United States
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Kentucky
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Louisiana
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Opelousas, Louisiana, United States
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Shreveport, Louisiana, United States
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Maryland
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Baltimore, Maryland, United States
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Massachusetts
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Michigan
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Detroit, Michigan, United States
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Pontiac, Michigan, United States
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Missouri
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Kansas City, Missouri, United States
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Saint Louis, Missouri, United States
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Montana
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Butte, Montana, United States
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Nebraska
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Omaha, Nebraska, United States
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New Jersey
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Englewood, New Jersey, United States
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Hackensack, New Jersey, United States
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New York
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Buffalo, New York, United States
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Mineola, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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North Carolina
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Ohio
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Pennsylvania
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Danville, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Rhode Island
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Providence, Rhode Island, United States
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South Carolina
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Columbia, South Carolina, United States
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Tennessee
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Texas
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Fort Worth, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Virginia
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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Washington
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Tacoma, Washington, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
INCLUSION CRITERIA:
- Age >= 18 years
Confirmed early-onset severe sepsis, defined as:
o---Objective evidence of infection likely to be caused by a bacterial or fungal pathogen
o---Presence of at least 3 of 4 systemic inflammatory response syndrome (SIRS) criteria
o---Sepsis-associated organ dysfunction
- Baseline Acute Physiology and Chronic Health Evaluation II (Apache II) Score of 21 to 37
- < 12 hours between onset of the first qualifying organ dysfunction and expected administration of study drug
- A commitment to full patient support
EXCLUSION CRITERIA:
- Pregnancy or breastfeeding
- Extensive (>20% Body Surface Area) third-degree burns
- Weight > 150 kg at admission
- Patients whose death from sepsis is considered imminent
- Patients not expected to survive for at least 2 months due to a pre-existing and uncorrectable medical condition, or those in a chronic vegetative state
- Patients with severe congestive heart failure
- Patients currently receiving immunosuppressive therapy such as cyclosporine, azathioprine, or cancer chemotherapy
- Patients with granulocyte counts < 1000/mm^3 unless the decreased count is believed to be due to sepsis
- Patients that required cardiopulmonary resuscitation in the 4 weeks prior to evaluation for enrollment
- Human immunodeficiency virus (HIV)-positive patients with CD4 count <= 50/mm^3 within 4 weeks of enrollment, or end-stage processes
- Patients with significant hepatic impairment, portal hypertension, or esophageal varices
- Patients who are expected to be treated with endotoxin-removal devices
- Patients with active cancer
- Patients receiving polymyxin B or colistin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: 2
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Matching placebo; intravenous infusion.
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EXPERIMENTAL: 1
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Intravenous infusion at a total dose of 105 mg.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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All-cause mortality at Day 28.
Time Frame: 28 days
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28 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dan Rossignol, Eisai Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2006
Primary Completion (ACTUAL)
January 1, 2011
Study Registration Dates
First Submitted
June 6, 2006
First Submitted That Met QC Criteria
June 6, 2006
First Posted (ESTIMATE)
June 8, 2006
Study Record Updates
Last Update Posted (ACTUAL)
July 25, 2017
Last Update Submitted That Met QC Criteria
July 21, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E5564-G000-301
- 2005-005537-35 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.