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

December 8, 2005 updated by: Eisai Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • California
      • San Diego, California, United States, 92134
      • Santa Barbara, California, United States, 93105
    • Florida
      • Jacksonville, Florida, United States, 32209
      • Miami, Florida, United States, 33125
      • Pensacola, Florida, United States, 32504
    • Georgia
      • Columbus, Georgia, United States, 31902
    • Illinois
      • Elk Grove, Illinois, United States, 60007
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Springfield, Massachusetts, United States, 01199
    • New York
      • Buffalo, New York, United States, 14203
      • Manhasset, New York, United States, 11030
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Texas
      • Dallas, Texas, United States, 75390
      • Galveston, Texas, United States, 77555
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: Alec Wittek, M.D., Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

September 19, 2002

First Submitted That Met QC Criteria

September 19, 2002

First Posted (Estimate)

September 20, 2002

Study Record Updates

Last Update Posted (Estimate)

December 12, 2005

Last Update Submitted That Met QC Criteria

December 8, 2005

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E5564-A001-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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