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ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334828
Recruitment Status : Completed
First Posted : June 8, 2006
Last Update Posted : July 25, 2017
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Drug: eritoran tetrasodium Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
Study Start Date : June 2006
Actual Primary Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: eritoran tetrasodium
Intravenous infusion at a total dose of 105 mg.
Placebo Comparator: 2 Drug: Placebo
Matching placebo; intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality at Day 28. [ Time Frame: 28 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334828


Locations
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Sponsors and Collaborators
Eisai Inc.
Investigators
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Study Director: Dan Rossignol Eisai Inc.
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00334828    
Other Study ID Numbers: E5564-G000-301
2005-005537-35 ( EudraCT Number )
First Posted: June 8, 2006    Key Record Dates
Last Update Posted: July 25, 2017
Last Verified: July 2017
Keywords provided by Eisai Inc.:
Severe sepsis
septic shock
sepsis
Additional relevant MeSH terms:
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Sepsis
Toxemia
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes