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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Argentina
      • Buenos Aires, Argentina
      • Cordoba, Argentina
      • Santa Fe, Argentina
  • Australia
      • Box Hill, Australia
      • New South Wales, Australia
      • Queensland, Australia
    • New South Wales
      • St. Leonards, New South Wales, Australia
      • Westmead, New South Wales, Australia
    • Queensland
      • Southport, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia
      • Woodville, South Australia, Australia
    • Victoria
      • Heidelberg, Victoria, Australia
      • Melbourne, Victoria, Australia
      • Parkville, Victoria, Australia
    • Western Australia
      • Nedlands, Western Australia, Australia
      • Perth, Western Australia, Australia
  • Austria
      • Salzburg, Austria
      • Wien, Austria
  • Belgium
      • Braine-l'Alleud, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Liege, Belgium
      • Mons, Belgium
      • Ottignies, Belgium
      • Seraing, Belgium
      • Yvoir, Belgium
  • Brazil
      • Belo Horizonte, Brazil
      • Curitba, Brazil
      • Fontaleza, Brazil
      • Joinville, Brazil
      • Porto Alegro, Brazil
      • Rio de Janeiro, Brazil
      • Sao Paulo, Brazil
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Toronto, Ontario, Canada
      • Windsor, Ontario, Canada
    • Quebec
      • Greenfield Park, Quebec, Canada
      • Montreal, Quebec, Canada
      • Quebec City, Quebec, Canada
  • Chile
      • Santiago, Chile
      • Temuco, Chile
      • Valdivia, Chile
      • Vina del Mar, Chile
  • Czechia
      • Brno, Czechia
      • Havlickuv Brod, Czechia
      • Hradec Kralove, Czechia
      • Plyzen, Czechia
      • Praha, Czechia
  • France
      • Amiens, France
      • Besancon, France
      • Colombes, France
      • Corbeil Essonnes, France
      • Evry Courcouronnes, France
      • La Roche sur Yon, France
      • La Tronche, France
      • Le Chesnay, France
      • Limoges, France
      • Montauban, France
      • Nimes, France
      • Paris, France
      • Saint-Michel, France
      • Tours, France
  • Germany
      • Aachen, Germany
      • Berlin, Germany
      • Bonn, Germany
      • Erfurt, Germany
      • Erlangen, Germany
      • Frankfurt, Germany
      • Geissen, Germany
      • Hannover, Germany
      • Jena, Germany
      • Koln, Germany
      • Krefeld, Germany
      • Ludwigshafen, Germany
      • Munchen, Germany
  • Hong Kong
      • Hong Kong, Hong Kong
  • Israel
      • Afula, Israel
      • Hadera, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Nahariya, Israel
      • Petah-Tikva, Israel
      • Tel Hashomer, Israel
      • Zerifin, Israel
  • Italy
      • Bari, Italy
      • Busto Arsizio, Italy
      • Cesana, Italy
      • Milan, Italy
      • Monza, Italy
      • Novara, Italy
      • Pavia, Italy
      • Trieste, Italy
      • Verona, Italy
  • Japan
      • Aichi, Japan
      • Bunkyo, Japan
      • Chuo, Japan
      • Fukuoka, Japan
      • Fukushima, Japan
      • Hachioji, Japan
      • Hamamatsu, Japan
      • Hirosaki City, Japan
      • Hiroshima, Japan
      • Iizuka, Japan
      • Itabashi, 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, Japan
      • Suita, Japan
      • Ube, Japan
      • Utsunomiya, Japan
      • Yonago, Japan
      • Yotsukaidou, Japan
  • Korea, Republic of
      • Seoul, Korea, Republic of
  • Netherlands
      • Amsterdam, Netherlands
      • Apeldoorn, Netherlands
      • Ede, Netherlands
      • Groningen, Netherlands
      • Leeuwarden, Netherlands
      • Rotterdam, Netherlands
      • Tilburg, Netherlands
      • Utrecht, Netherlands
      • Zwolle, Netherlands
      • s'Hertogenbosch, Netherlands
  • Poland
      • Bielsko Biala, Poland
      • Groszisk Mazowiecki, Poland
      • Krakow, Poland
      • Lodz, Poland
      • Poznan, Poland
      • Warsaw, Poland
  • Portugal
      • Almada, Portugal
      • Amadora, Portugal
      • Lisbon, Portugal
  • South Africa
      • 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
  • Spain
      • Alcala de Henares Madrid, Spain
      • Barcelona, Spain
      • Burgos, Spain
      • Cataluna, Spain
      • Getafe, Spain
      • Madrid, Spain
      • Sabadell, Spain
      • Santiago de Compostela, Spain
      • Tarragona, Spain
  • Switzerland
      • Bern, Switzerland
      • Geneva, Switzerland
      • Lausanne, Switzerland
  • Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
      • Taoyuan, Taiwan
      • Yung Kang City, Taiwan
  • United Kingdom
      • Birmingham, United Kingdom
      • Leeds, United Kingdom
      • Livingston, United Kingdom
      • London, United Kingdom
      • Nottingham, United Kingdom
      • Plymouth, United Kingdom
      • Southampton, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
    • California
      • Loma Linda, California, United States
      • Marysville, California, United States
      • Orange, California, United States
      • San Diego, California, United States
      • Santa Barbara, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States
    • Florida
      • Atlantis, Florida, United States
      • Clearwater, Florida, United States
      • Gainesville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Pensacola, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Decatur, Georgia, United States
    • Idaho
      • Idaho Falls, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
      • Oak Park, Illinois, United States
      • Peoria, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Iowa
      • Des Moines, Iowa, United States
      • Iowa City, Iowa, United States
    • Kansas
      • Kansas City, Kansas, United States
      • Topeka, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Opelousas, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Springfield, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
      • Pontiac, Michigan, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Montana
      • Butte, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New Jersey
      • Englewood, New Jersey, United States
      • Hackensack, New Jersey, United States
    • New York
      • 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
    • North Carolina
      • Durham, North Carolina, United States
      • Greenville, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Danville, Pennsylvania, United States
      • Hershey, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Lubbock, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
      • Norfolk, Virginia, United States
      • Roanoke, Virginia, United States
    • Washington
      • Tacoma, Washington, United States

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: 2
Drug: Placebo
Matching placebo; intravenous infusion.
EXPERIMENTAL: 1
Drug: eritoran tetrasodium
Intravenous infusion at a total dose of 105 mg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
All-cause mortality at Day 28.
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2006

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2006

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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