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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00334828
First received: June 6, 2006
Last updated: June 30, 2014
Last verified: January 2013
  Purpose

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 Intervention Phase
Severe Sepsis
Drug: eritoran tetrasodium
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • All-cause mortality at Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 2000
Study Start Date: June 2006
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: eritoran tetrasodium
Intravenous infusion at a total dose of 105 mg.
Placebo Comparator: 2 Drug: Placebo
Matching placebo; intravenous infusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00334828

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Locations
United States, Alabama
Birmingham, Alabama, United States
Mobile, Alabama, United States
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Mesa, Arizona, United States
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Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Dan Rossignol Eisai Inc.
  More Information

No publications provided by Eisai Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00334828     History of Changes
Other Study ID Numbers: E5564-G000-301, 2005-005537-35
Study First Received: June 6, 2006
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Severe sepsis
septic shock
sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014