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

• ClinicalTrials.gov Identifier: NCT00334828
• Recruitment Status: Completed
• First Posted: June 8, 2006
• Last Update Posted: July 25, 2017
• Sponsor: Eisai Inc.
• Information provided by (Responsible Party): Eisai Inc.

Tracking Information

• First Submitted Date: June 6, 2006
• First Posted Date: June 8, 2006
• Last Update Posted Date: July 25, 2017
• Study Start Date: June 2006
• Actual Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 16, 2010): All-cause mortality at Day 28. [ Time Frame: 28 days ]
• Original Primary Outcome Measures (submitted: June 6, 2006): Survival at day 28.
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: June 6, 2006): Survival at 12 months.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Severe Sepsis

Intervention

• Drug: eritoran tetrasodium
  Intravenous infusion at a total dose of 105 mg.
• Drug: Placebo
  Matching placebo; intravenous infusion.

Study Arms

• Experimental: 1
  Intervention: Drug: eritoran tetrasodium
• Placebo Comparator: 2
  Intervention: Drug: Placebo

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 2, 2006): 2000
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, South Africa, Spain, Switzerland, Taiwan, United Kingdom, United States
• Removed Location Countries: China, Czech Republic, Mexico, Puerto Rico

Administrative Information

• NCT Number: NCT00334828
• Other Study ID Numbers: E5564-G000-301; 2005-005537-35 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eisai Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Eisai Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Dan Rossignol; Eisai Inc.

• PRS Account: Eisai Inc.
• Verification Date: July 2017