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

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