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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334828

  Show 251 Study Locations
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 July 20, 2014