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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00046072
First received: September 19, 2002
Last updated: December 8, 2005
Last verified: December 2005
  Purpose

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 Intervention Phase
Sepsis
Shock, Septic
Sepsis Syndrome
Septicemia
Infection
Drug: E5564
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Estimated Enrollment: 300
Study Start Date: October 2001
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046072

Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, California
San Diego, California, United States, 92134
Santa Barbara, California, United States, 93105
United States, Florida
Jacksonville, Florida, United States, 32209
Miami, Florida, United States, 33125
Pensacola, Florida, United States, 32504
United States, Georgia
Columbus, Georgia, United States, 31902
United States, Illinois
Elk Grove, Illinois, United States, 60007
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Springfield, Massachusetts, United States, 01199
United States, New York
Buffalo, New York, United States, 14203
Manhasset, New York, United States, 11030
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Texas
Dallas, Texas, United States, 75390
Galveston, Texas, United States, 77555
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Alec Wittek, M.D. Eisai Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00046072     History of Changes
Other Study ID Numbers: E5564-A001-201
Study First Received: September 19, 2002
Last Updated: December 8, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Sepsis
Shock
Septic
Sepsis Syndrome
Septicemia
Endotoxins
Endotoxemia
Infection

Additional relevant MeSH terms:
Infection
Sepsis
Shock, Septic
Syndrome
Systemic Inflammatory Response Syndrome
Toxemia
Disease
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on November 25, 2014