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
1 other identifier
interventional
300
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 sepsis
Started Oct 2001
Longer than P75 for phase_2 sepsis
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 19, 2002
CompletedFirst Posted
Study publicly available on registry
September 20, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedDecember 12, 2005
December 1, 2005
September 19, 2002
December 8, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Cardiogenic or hypovolemic shock.
- Acute third degree burns involving \>20% of body surface.
- Recipients of non-autologous organ transplants within the past year.
- Pregnancy.
- Chronic vegetative state.
- Uncontrolled serious hemorrhage (.2 units of blood/platelets in the previous 24 hours). Patients may be considered for enrollment if bleeding has stopped and patients are still otherwise qualified.
- Unwilling or unable to be fully evaluated for all follow-up visits.
- Patients who are classified as "Do not resusitate" or "Do not treat."
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (17)
Unknown Facility
Mobile, Alabama, 36608, United States
Unknown Facility
San Diego, California, 92134, United States
Unknown Facility
Santa Barbara, California, 93105, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Miami, Florida, 33125, United States
Unknown Facility
Pensacola, Florida, 32504, United States
Unknown Facility
Columbus, Georgia, 31902, United States
Unknown Facility
Elk Grove, Illinois, 60007, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Springfield, Massachusetts, 01199, United States
Unknown Facility
Buffalo, New York, 14203, United States
Unknown Facility
Manhasset, New York, 11030, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Dallas, Texas, 75390, United States
Unknown Facility
Galveston, Texas, 77555, United States
Unknown Facility
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alec Wittek, M.D.
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 19, 2002
First Posted
September 20, 2002
Study Start
October 1, 2001
Study Completion
April 1, 2005
Last Updated
December 12, 2005
Record last verified: 2005-12