Status:
COMPLETED
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
Lead Sponsor:
Eisai Inc.
Conditions:
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare eritoran tetrasodium and placebo in patients with severe sepsis and to demonstrate a reduction of mortality from all causes.
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age \>= 18 years
- Confirmed early-onset severe sepsis, defined as:
- o---Objective evidence of infection likely to be caused by a bacterial or fungal pathogen
- o---Presence of at least 3 of 4 systemic inflammatory response syndrome (SIRS) criteria
- o---Sepsis-associated organ dysfunction
- Baseline Acute Physiology and Chronic Health Evaluation II (Apache II) Score of 21 to 37
- \< 12 hours between onset of the first qualifying organ dysfunction and expected administration of study drug
- A commitment to full patient support
- EXCLUSION CRITERIA:
- Pregnancy or breastfeeding
- Extensive (\>20% Body Surface Area) third-degree burns
- Weight \> 150 kg at admission
- Patients whose death from sepsis is considered imminent
- Patients not expected to survive for at least 2 months due to a pre-existing and uncorrectable medical condition, or those in a chronic vegetative state
- Patients with severe congestive heart failure
- Patients currently receiving immunosuppressive therapy such as cyclosporine, azathioprine, or cancer chemotherapy
- Patients with granulocyte counts \< 1000/mm\^3 unless the decreased count is believed to be due to sepsis
- Patients that required cardiopulmonary resuscitation in the 4 weeks prior to evaluation for enrollment
- Human immunodeficiency virus (HIV)-positive patients with CD4 count \<= 50/mm\^3 within 4 weeks of enrollment, or end-stage processes
- Patients with significant hepatic impairment, portal hypertension, or esophageal varices
- Patients who are expected to be treated with endotoxin-removal devices
- Patients with active cancer
- Patients receiving polymyxin B or colistin
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00334828
Start Date
June 1 2006
Last Update
July 25 2017
Active Locations (251)
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1
Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Mesa, Arizona, United States
4
Loma Linda, California, United States