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Sponsored by: |
Eisai Medical Research Inc. |
---|---|
Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00046072 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Study of E5564, A Lipid A Antagonist, Administered by Twice Daily Infusions in Patients With Severe Sepsis |
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
Pensacola, Florida, United States, 32504 | |
Jacksonville, Florida, United States, 32209 | |
Miami, Florida, United States, 33125 | |
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 | |
Manhasset, New York, United States, 11030 | |
Buffalo, New York, United States, 14203 | |
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 |
Study Director: | Alec Wittek, M.D. | Eisai Medical Research Inc. |
Study ID Numbers: | E5564-A001-201 |
Study First Received: | September 19, 2002 |
Last Updated: | December 8, 2005 |
ClinicalTrials.gov Identifier: | NCT00046072 |
Health Authority: | United States: Food and Drug Administration |
Sepsis Shock Septic Sepsis Syndrome |
Septicemia Endotoxins Endotoxemia Infection |
Systemic Inflammatory Response Syndrome Sepsis Shock |
Shock, Septic Endotoxemia Inflammation |
Disease Pathologic Processes Syndrome Infection |