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A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis Clinical research trials and A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis. A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis clinical trial. Participants oftentimes recieve the most expert healthcare available for their A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis  A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis
A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis
For Condition: Sepsis,Infection,Shock, Septic,Sepsis Syndrome,Septicemia
Status: Recruiting
Sponsor(s): Eisai Medical Research Inc ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol Entry 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 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.
Total Enrollment: 300
Location and Contact Information:
Overall Study Official:
AlecWittek, Study Director, Eisai Medical Research Inc
Additional Information:
Study ID Numbers: E5564-A001-201;
Study Start Date: October 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046072
Other Sepsis Syndrome Studies:
1. A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis
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A Safety and Efficacy Study of Intravenous E5564 in Patients with Severe Sepsis
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