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

June 6, 2006
June 30, 2014
June 2006
January 2011   (final data collection date for primary outcome measure)
All-cause mortality at Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Survival at day 28.
Complete list of historical versions of study NCT00334828 on ClinicalTrials.gov Archive Site
Not Provided
Survival at 12 months.
Not Provided
Not Provided
 
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Severe Sepsis
  • Drug: eritoran tetrasodium
    Intravenous infusion at a total dose of 105 mg.
  • Drug: Placebo
    Matching placebo; intravenous infusion.
  • Experimental: 1
    Intervention: Drug: eritoran tetrasodium
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
Not Provided
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   United States,   United Kingdom,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   Czech Republic,   France,   Germany,   Hong Kong,   Israel,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Portugal,   South Africa,   Spain,   Switzerland,   Taiwan
 
NCT00334828
E5564-G000-301, 2005-005537-35
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Dan Rossignol Eisai Inc.
Eisai Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP