Severe SepsisPhase 3NCT00334828
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
A Phase 3 study testing eritoran tetrasodium in people with Severe Sepsis, run by Eisai Inc. at 251 sites in 24 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- eritoran tetrasodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 251 sitesin 24 countries
- Study dates
- Jun 2006to Jan 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
251 sites in 24 countries.
251 sites in 24 countries
United States69 sites
Study site
Atlanta, Georgia
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Atlantis, Florida
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Baltimore, Maryland
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Birmingham, Alabama
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Boston, Massachusetts
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Buffalo, New York
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Butte, Montana
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Charlottesville, Virginia
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Chicago, Illinois
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Clearwater, Florida
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Cleveland, Ohio
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Columbia, South Carolina
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Columbus, Ohio
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Danville, Pennsylvania
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Decatur, Georgia
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Denver, Colorado
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Des Moines, Iowa
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Detroit, Michigan
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Durham, North Carolina
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Englewood, New Jersey
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Fort Worth, Texas
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Gainesville, Florida
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Greenville, North Carolina
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Hackensack, New Jersey
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Hershey, Pennsylvania
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Houston, Texas
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Iowa City, Iowa
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Kansas City, Kansas
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Kansas City, Missouri
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Lexington, Kentucky
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Loma Linda, California
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Louisville, Kentucky
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Lubbock, Texas
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Marysville, California
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Memphis, Tennessee
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Mesa, Arizona
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Miami, Florida
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Mineola, New York
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Mobile, Alabama
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Nashville, Tennessee
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New Haven, Connecticut
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New Hyde Park, New York
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New York, New York
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Newark, Delaware
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Norfolk, Virginia
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Oak Park, Illinois
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Omaha, Nebraska
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Opelousas, Louisiana
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Orange, California
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Orlando, Florida
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Pensacola, Florida
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Peoria, Illinois
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania
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Pontiac, Michigan
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Providence, Rhode Island
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Roanoke, Virginia
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Rochester, New York
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San Diego, California
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Santa Barbara, California
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Shreveport, Louisiana
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Springfield, Massachusetts
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St Louis, Missouri
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Tacoma, Washington
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Toledo, Ohio
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Topeka, Kansas
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Washington D.C., District of Columbia
Japan30 sites
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Aichi
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Bunkyō City
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Chūō
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Fukuoka
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Fukushima
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Hachiōji
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Hamamatsu
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Hirosaki
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Hiroshima
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Iizuka
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Kagoshima
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Kamagaya
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Kanagawa
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Kishiwada
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Kobe
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Kochi
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Kumamoto
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Kyoto
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Morioka
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Osaka
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Saga
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Sapporo
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Sendai
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Shinagawa City
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Suita
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tabashi City
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Ube
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Utsunomiya
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Yonago
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Yotsukaidou
France14 sites
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Amiens
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Besançon
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Colombes
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Corbeil-Essonnes
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Evry Courcouronnes
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La Roche-sur-Yon
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La Tronche
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Le Chesnay
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Limoges
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Montauban
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Nîmes
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Paris
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Saint-Michel
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Tours
Australia13 sites
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Adelaide, South Australia
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Box Hill
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Heidelberg, Victoria
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Melbourne, Victoria
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Nedlands, Western Australia
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New South Wales, New South Wales
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Parkville, Victoria
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Perth, Western Australia
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Queensland, Queensland
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Southport, Queensland
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St Leonards, New South Wales
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Westmead, New South Wales
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Woodville, South Australia
Germany13 sites
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Aachen
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Berlin
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Bonn
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Cologne
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Erfurt
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Erlangen
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Frankfurt
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Geißen
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Hanover
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Jena
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Krefeld
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Ludwigshafen
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München
Canada12 sites
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Calgary, Alberta
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Edmonton, Alberta
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Greenfield Park, Quebec
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Halifax, Nova Scotia
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Montreal, Quebec
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Québec, Quebec
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Saint John, New Brunswick
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Toronto, Ontario
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Vancouver, British Columbia
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Victoria, British Columbia
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Windsor, Ontario
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Winnipeg, Manitoba
Israel10 sites
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Afula
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Hadera
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Haifa
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Holon
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Jerusalem
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Kfar Saba
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Nahariya
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Petah Tikva
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Tel HaShomer
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Tsrifin
Netherlands10 sites
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Amsterdam
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Apeldoorn
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Ede
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Groningen
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Leeuwarden
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Rotterdam
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s'Hertogenbosch
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Tilburg
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Utrecht
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Zwolle
Italy9 sites
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Bari
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Busto Arsizio
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Cesana Torinese
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Milan
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Monza
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Novara
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Pavia
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Trieste
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Verona
Spain9 sites
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Alcala de Henares Madrid
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Barcelona
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Burgos
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Cataluna
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Getafe
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Madrid
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Sabadell
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Santiago de Compostela
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Tarragona
Belgium8 sites
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Braine-l'Alleud
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Brussels
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Ghent
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Liège
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Mons
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Ottignies
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Seraing
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Yvoir
South Africa8 sites
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Alberton
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Cape Town
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Centurion
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Johannesburg
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Kimberley
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Parow
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Pietermaritzburg
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Roodepoort
Brazil7 sites
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Belo Horizonte
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Curitba
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Fontaleza
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Joinville
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Porto Alegre
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Rio de Janeiro
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São Paulo
United Kingdom7 sites
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Birmingham
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Leeds
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Livingston
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London
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Nottingham
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Plymouth
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Southampton
Poland6 sites
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Bielsko-Biala
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Groszisk Mazowiecki
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Krakow
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Lodz
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Poznan
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Warsaw
Czechia5 sites
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Brno
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Havlíčkův Brod
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Hradec Králové
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Plyzen
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Prague
Chile4 sites
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Santiago
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Temuco
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Valdivia
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Viña del Mar
Taiwan4 sites
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Taichung
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Taipei
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Taoyuan
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Yung Kang City
Argentina3 sites
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Buenos Aires
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Córdoba
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Santa Fe
About this study
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.
- Conditions
- Severe Sepsis
- Being tested
- eritoran tetrasodium, Placebo
- Keywords
- Severe sepsis, septic shock, sepsis
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eritoran tetrasodiumDrug
Intravenous infusion at a total dose of 105 mg.
PlaceboDrug
Matching placebo; intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: eritoran tetrasodium |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at Day 28.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Rossignol, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334828
- Sponsor's protocol ID
- E5564-G000-301
- Other IDs
- 2005-005537-35, 2005
- Status last verified
- Jul 2017
- First submitted
- 6 Jun 2006
- Last updated
- 25 Jul 2017
- Results posted
- No
Publications
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.
PubMed 23512062
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT00334828
- Acronym / sponsor ID
- E5564-G000-301
- Conditions
- Severe Sepsis
- Keywords
- Severe sepsis, septic shock, sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Jan 2011 (actual)
- First posted
- 8 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: eritoran tetrasodium |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eritoran tetrasodiumIntravenous infusion at a total dose of 105 mg. | Drug | 1 |
| PlaceboMatching placebo; intravenous infusion. | Drug | 2 |
Primary outcome
All-cause mortality at Day 28.
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Derived from this study: PubMed 23512062Opal 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.
- Link to EUCTR resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Rossignol study director
Eisai Inc.
251 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing eritoran tetrasodium in people with Severe Sepsis, run by Eisai Inc. at 251 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 251 sites in United States, Japan, France, Australia, Germany and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality at Day 28. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00334828, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017.