This is a randomized, double-blind, placebo-controlled study. Recruitment will be from approximately 250 sites in the US, Canada, EU, IL, AU/NZ, South Africa, Chile, Argentina, Brazil, Mexico and Japan. Subjects will be randomly assigned to one of two treatment groups (eritoran or placebo administered every 12 hours for a total of 11 doses) after a baseline assessment.

• Drug: SGEA
• Drug: Placebo

INCLUSION CRITERIA:

• Age >= 18 years

• Confirmed early onset severe sepsis, defined as:

  • Objective evidence of infection likely to be caused by a bacterial or fungal pathogen.
  • Presence of at least 3 of 4 SIRS criteria
  • Sepsis-associated organ dysfunction
  • Baseline Apache II Score of 21 to 37
• < 12 hour between onset of the first qualifying organ dysfunction and expected administration of study drug
• A commitment to full patient support

EXCLUSION CRITERIA:

• Pregnancy
• Extensive (>20% BSA) 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
• 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