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.
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