ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
2 other identifiers
interventional
2,000
23 countries
238
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
238 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 6, 2006
CompletedFirst Posted
Study publicly available on registry
June 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedJuly 25, 2017
July 1, 2017
4.6 years
June 6, 2006
July 21, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause mortality at Day 28.
28 days
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (251)
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Mesa, Arizona, United States
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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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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Newark, Delaware, United States
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Washington D.C., District of Columbia, United States
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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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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Idaho Falls, Idaho, United States
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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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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Opelousas, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Springfield, Massachusetts, United States
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Detroit, Michigan, United States
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Pontiac, Michigan, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Omaha, Nebraska, United States
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Englewood, New Jersey, United States
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Hackensack, New Jersey, United States
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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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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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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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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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Providence, Rhode Island, United States
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Columbia, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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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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Charlottesville, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Tacoma, Washington, United States
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Buenos Aires, Argentina
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Córdoba, Argentina
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Santa Fe, Argentina
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New South Wales, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Westmead, New South Wales, Australia
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Queensland, Queensland, Australia
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Southport, Queensland, Australia
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Adelaide, South Australia, Australia
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Woodville, South Australia, Australia
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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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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Box Hill, Australia
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Salzburg, Austria
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Vienna, Austria
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Braine-l'Alleud, Belgium
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Brussels, Belgium
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Ghent, Belgium
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Liège, 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 Alegre, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, 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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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Santiago, Chile
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Temuco, Chile
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Valdivia, Chile
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Viña del Mar, Chile
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Brno, Czechia
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Havlíčkův Brod, Czechia
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Hradec Králové, Czechia
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Plyzen, Czechia
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Prague, Czechia
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Amiens, France
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Besançon, 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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Nîmes, 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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Cologne, 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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Hanover, Germany
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Jena, Germany
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Krefeld, Germany
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Ludwigshafen, Germany
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München, 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 Litwinsky, Israel
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Ẕerifin, Israel
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Bari, Italy
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Busto Arsizio, Italy
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Cesana Torinese, 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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Bunkyō City, Japan
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Chūō, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Hachiōji, Japan
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Hamamatsu, Japan
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Hirosaki, Japan
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Hiroshima, Japan
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Iizuka, 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 City, Japan
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Suita, Japan
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tabashi City, 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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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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s'Hertogenbosch, Netherlands
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Tilburg, Netherlands
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Utrecht, Netherlands
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Zwolle, 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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Seoul, South Korea
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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 District, 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
Related Publications (1)
Opal SM, Laterre PF, Francois B, LaRosa SP, Angus DC, Mira JP, Wittebole X, Dugernier T, Perrotin D, Tidswell M, Jauregui L, Krell K, Pachl J, Takahashi T, Peckelsen C, Cordasco E, Chang CS, Oeyen S, Aikawa N, Maruyama T, Schein R, Kalil AC, Van Nuffelen M, Lynn M, Rossignol DP, Gogate J, Roberts MB, Wheeler JL, Vincent JL; ACCESS Study Group. Effect of eritoran, an antagonist of MD2-TLR4, on mortality in patients with severe sepsis: the ACCESS randomized trial. JAMA. 2013 Mar 20;309(11):1154-62. doi: 10.1001/jama.2013.2194.
PMID: 23512062DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dan Rossignol
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2006
First Posted
June 8, 2006
Study Start
June 1, 2006
Primary Completion
January 1, 2011
Last Updated
July 25, 2017
Record last verified: 2017-07