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

NCT ID: NCT00046072

Last Updated: 2005-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2005-04-30

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.

Conditions

Sepsis; Shock, Septic; Sepsis Syndrome; Septicemia; Infection

Keywords

Sepsis; Shock; Septic; Sepsis Syndrome; Septicemia; Endotoxins; Endotoxemia; Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

E5564

Intervention Type: DRUG

Eligibility Criteria

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.

Exclusion Criteria

• 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."

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Alec Wittek, M.D.

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

Mobile, Alabama, United States

San Diego, California, United States

Santa Barbara, California, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Pensacola, Florida, United States

Columbus, Georgia, United States

Elk Grove, Illinois, United States

Kansas City, Kansas, United States

Boston, Massachusetts, United States

Springfield, Massachusetts, United States

Buffalo, New York, United States

Manhasset, New York, United States

Oklahoma City, Oklahoma, United States

Dallas, Texas, United States

Galveston, Texas, United States

San Antonio, Texas, United States

Countries

United States

Other Identifiers

E5564-A001-201

Identifier Type: -

Identifier Source: org_study_id