Lead Sponsor

Eisai Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

•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

•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

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