A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis

Inclusion Criteria

• •Presently admitted, or about to be transferred, to the ICU.
• •Women of Child-bearing potential must have a negative serum (or urine) hCG assay within 24 hours prior to drug administration.
• •Any Race.
• •Severe Sepsis \[newly developed respiratory failure, refractory shock, renal dysfunction, hepatic dysfunction, or metabolic acidosis and at least three signs of SIRS (systematic inflammatory response syndrome)\].
• •Objective signs of infection likely to be caused by a bacterial or fungal pathogen.
• •Patients must receive study medication within 8 to 12 hours of recognition of the initial sepsis-related organ failure.
• •APACHE Predicted risk of mortality score between 20% and 80%.
• •An intent by physicians and family to aggressively treat the patient for the 28 day study period.
• •Patients with a predicted risk of mortality score of \<20% or \>80% after recognition of qualifying organ failure.
• •Patients with a predicted risk of mortality of \<51% for whom Xigris® use is planned.