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