Clinical trial NCT00334828: ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
Official title: ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Sepsis
Keywords: Severe sepsis
septic shock
sepsis
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-06-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality at Day 28.
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
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country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Loma Linda
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state: California
city: Marysville
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state: California
city: Orange
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state: California
city: San Diego
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state: California
city: Santa Barbara
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state: California
city: Denver
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state: Colorado
city: New Haven
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state: Connecticut
city: Newark
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state: Delaware
city: Washington, D.C.
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state: District of Columbia
city: Atlantis
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state: Florida
city: Clearwater
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state: Florida
city: Gainesville
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city: Montreal
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city: Quebec City
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city: Havlickuv Brod
country: Czechia
city: Hradec Kralove
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city: Plyzen
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city: Praha
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city: Amiens
country: France
city: Besancon
country: France
city: Colombes
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city: Corbeil Essonnes
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city: Evry Courcouronnes
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city: Limoges
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city: Montauban
country: France
city: Nimes
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city: Paris
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city: Saint-Michel
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city: Tours
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city: Aachen
country: Germany
city: Berlin
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city: Bonn
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city: Erfurt
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city: Erlangen
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city: Frankfurt
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city: Geissen
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city: Hannover
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city: Jena
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city: Koln
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city: Krefeld
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city: Kumamoto
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city: Kyoto
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city: Morioka
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city: Osaka
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city: Saga
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city: Sapporo
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city: Sendai
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city: Shinagawa
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city: Suita
country: Japan
city: Ube
country: Japan
city: Utsunomiya
country: Japan
city: Yonago
country: Japan
city: Yotsukaidou
country: Japan
city: Seoul
country: Korea, Republic of
city: Amsterdam
country: Netherlands
city: Apeldoorn
country: Netherlands
city: Ede
country: Netherlands
city: Groningen
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Rotterdam
country: Netherlands
city: s'Hertogenbosch
country: Netherlands
city: Tilburg
country: Netherlands
city: Utrecht
country: Netherlands
city: Zwolle
country: Netherlands
city: Bielsko Biala
country: Poland
city: Groszisk Mazowiecki
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Warsaw
country: Poland
city: Almada
country: Portugal
city: Amadora
country: Portugal
city: Lisbon
country: Portugal
city: Alberton
country: South Africa
city: Cape Town
country: South Africa
city: Centurion
country: South Africa
city: Johannesburg
country: South Africa
city: Kimberley
country: South Africa
city: Parow
country: South Africa
city: Pietermaritzburg
country: South Africa
city: Roodepoort
country: South Africa
city: Alcala de Henares Madrid
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Cataluna
country: Spain
city: Getafe
country: Spain
city: Madrid
country: Spain
city: Sabadell
country: Spain
city: Santiago de Compostela
country: Spain
city: Tarragona
country: Spain
city: Bern
country: Switzerland
city: Geneva
country: Switzerland
city: Lausanne
country: Switzerland
city: Taichung
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
city: Yung Kang City
country: Taiwan
city: Birmingham
country: United Kingdom
city: Leeds
country: United Kingdom
city: Livingston
country: United Kingdom
city: London
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Eisai Inc.
name: Dan Rossignol
role: STUDY_DIRECTOR
References:
citation: 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.