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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046072
• Other study ID #: E5564-A001-201
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2002
• Last updated: December 8, 2005
• Start date: October 2001
• Est. completion date: April 2005

Study information

• Verified date: December 2005
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

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."

• Patients who develop severe sepsis <36 hours post trauma or post-surgery. Patients may be considered for enrollment >36 hours post-trauma or post-surgery, if they meet other inclusion criteria.

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection
• Sepsis
• Sepsis Syndrome
• Septicemia
• Shock, Septic
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

Drug:
• E5564

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States,