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

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00046072

Collaborator

(none)

300

Enrollment

Locations

Duration (Months)

17.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Shock, Septic Sepsis Syndrome Septicemia Infection	Drug: E5564	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2001

Study Completion Date :

Apr 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Mobile	Alabama	United States	36608
2	San Diego	California	United States	92134
3	Santa Barbara	California	United States	93105
4	Jacksonville	Florida	United States	32209
5	Miami	Florida	United States	33125
6	Pensacola	Florida	United States	32504
7	Columbus	Georgia	United States	31902
8	Elk Grove	Illinois	United States	60007
9	Kansas City	Kansas	United States	66160
10	Boston	Massachusetts	United States	02114
11	Springfield	Massachusetts	United States	01199
12	Buffalo	New York	United States	14203
13	Manhasset	New York	United States	11030
14	Oklahoma City	Oklahoma	United States	73104
15	Dallas	Texas	United States	75390
16	Galveston	Texas	United States	77555
17	San Antonio	Texas	United States	78229