ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
NCT ID: NCT00334828
Last Updated: 2017-07-25
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2000 participants
INTERVENTIONAL
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
NCT01598831
Efficacy & Safety of Resatorvid in Adults With Severe Sepsis
NCT00143611
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock
NCT00604214
A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients
NCT04612413
Epirubicin for the Treatment of Sepsis & Septic Shock
NCT05033808
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
eritoran tetrasodium
Intravenous infusion at a total dose of 105 mg.
2
Placebo
Matching placebo; intravenous infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
eritoran tetrasodium
Intravenous infusion at a total dose of 105 mg.
Placebo
Matching placebo; intravenous infusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eisai Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dan Rossignol
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Mobile, Alabama, United States
Mesa, Arizona, United States
Loma Linda, California, United States
Marysville, California, United States
Orange, California, United States
San Diego, California, United States
Santa Barbara, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Atlantis, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Oak Park, Illinois, United States
Peoria, Illinois, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Iowa City, Iowa, United States
Kansas City, Kansas, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Opelousas, Louisiana, United States
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Detroit, Michigan, United States
Pontiac, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Butte, Montana, United States
Omaha, Nebraska, United States
Englewood, New Jersey, United States
Hackensack, New Jersey, United States
Buffalo, New York, United States
Mineola, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Danville, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Columbia, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Lubbock, Texas, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Roanoke, Virginia, United States
Tacoma, Washington, United States
Buenos Aires, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
New South Wales, New South Wales, Australia
St Leonards, New South Wales, Australia
Westmead, New South Wales, Australia
Queensland, Queensland, Australia
Southport, Queensland, Australia
Adelaide, South Australia, Australia
Woodville, South Australia, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Parkville, Victoria, Australia
Nedlands, Western Australia, Australia
Perth, Western Australia, Australia
Box Hill, , Australia
Salzburg, , Austria
Vienna, , Austria
Braine-l'Alleud, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Liège, , Belgium
Mons, , Belgium
Ottignies, , Belgium
Seraing, , Belgium
Yvoir, , Belgium
Belo Horizonte, , Brazil
Curitba, , Brazil
Fontaleza, , Brazil
Joinville, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
Saint John, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Greenfield Park, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Santiago, , Chile
Temuco, , Chile
Valdivia, , Chile
Viña del Mar, , Chile
Brno, , Czechia
Havlíčkův Brod, , Czechia
Hradec Králové, , Czechia
Plyzen, , Czechia
Prague, , Czechia
Amiens, , France
Besançon, , France
Colombes, , France
Corbeil-Essonnes, , France
Evry Courcouronnes, , France
La Roche-sur-Yon, , France
La Tronche, , France
Le Chesnay, , France
Limoges, , France
Montauban, , France
Nîmes, , France
Paris, , France
Saint-Michel, , France
Tours, , France
Aachen, , Germany
Berlin, , Germany
Bonn, , Germany
Cologne, , Germany
Erfurt, , Germany
Erlangen, , Germany
Frankfurt, , Germany
Geißen, , Germany
Hanover, , Germany
Jena, , Germany
Krefeld, , Germany
Ludwigshafen, , Germany
München, , Germany
Hong Kong, , Hong Kong
Afula, , Israel
Hadera, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Nahariya, , Israel
Petah Tikva, , Israel
Tel Litwinsky, , Israel
Ẕerifin, , Israel
Bari, , Italy
Busto Arsizio, , Italy
Cesana Torinese, , Italy
Milan, , Italy
Monza, , Italy
Novara, , Italy
Pavia, , Italy
Trieste, , Italy
Verona, , Italy
Aichi, , Japan
Bunkyō City, , Japan
Chūō, , Japan
Fukuoka, , Japan
Fukushima, , Japan
Hachiōji, , Japan
Hamamatsu, , Japan
Hirosaki, , Japan
Hiroshima, , Japan
Iizuka, , Japan
Kagoshima, , Japan
Kamagaya, , Japan
Kanagawa, , Japan
Kishiwada, , Japan
Kobe, , Japan
Kochi, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Morioka, , Japan
Osaka, , Japan
Saga, , Japan
Sapporo, , Japan
Sendai, , Japan
Shinagawa City, , Japan
Suita, , Japan
tabashi City, , Japan
Ube, , Japan
Utsunomiya, , Japan
Yonago, , Japan
Yotsukaidou, , Japan
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Ede, , Netherlands
Groningen, , Netherlands
Leeuwarden, , Netherlands
Rotterdam, , Netherlands
s'Hertogenbosch, , Netherlands
Tilburg, , Netherlands
Utrecht, , Netherlands
Zwolle, , Netherlands
Bielsko-Biala, , Poland
Groszisk Mazowiecki, , Poland
Krakow, , Poland
Lodz, , Poland
Poznan, , Poland
Warsaw, , Poland
Almada, , Portugal
Amadora, , Portugal
Lisbon, , Portugal
Alberton, , South Africa
Cape Town, , South Africa
Centurion, , South Africa
Johannesburg, , South Africa
Kimberley, , South Africa
Parow, , South Africa
Pietermaritzburg, , South Africa
Roodepoort, , South Africa
Seoul, , South Korea
Alcala de Henares Madrid, , Spain
Barcelona, , Spain
Burgos, , Spain
Cataluna, , Spain
Getafe, , Spain
Madrid, , Spain
Sabadell, , Spain
Santiago de Compostela, , Spain
Tarragona, , Spain
Bern, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Taichung, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Yung Kang City, , Taiwan
Birmingham, , United Kingdom
Leeds, , United Kingdom
Livingston, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Plymouth, , United Kingdom
Southampton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Link to EUCTR results
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2005-005537-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E5564-G000-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.