NCT00046072

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

A Double-Blind, Placebo-Controlled Study of E5564, A Lipid A Antagonist, Administered by Twice Daily Infusions in Patients With Severe Sepsis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (planned)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Sepsis is a serious condition where there is inflammation and damage to body tissue, usually caused by an infection. This infection can lead to decreased function of vital body organs and in some cases may lead to permanent health problems or death. Much of the injury is due to endotoxin, a harmful substance produced by certain types of bacteria. An endotoxin antagonist is designed to block the effects of endotoxin. This study is designed to study the safety and efficacy when treating patients with severe sepsis.

Conditions

• Sepsis
• Shock, Septic
• Sepsis Syndrome
• Septicemia
• Infection

Interventions

Type	Name	Description
DRUG	E5564

Timeline

• Start date: 2001-10-01
• Completion: 2005-04-01
• First posted: 2002-09-20
• Last updated: 2005-12-12

Locations

17 sites across 1 country: United States