Severe Sepsis
Conditions
Keywords
Severe sepsis, septic shock, sepsis
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.
Interventions
DRUGeritoran tetrasodium
Intravenous infusion at a total dose of 105 mg.
DRUGPlacebo
Matching placebo; intravenous infusion.
Sponsors
Eisai Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at Day 28. | 28 days |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Poland, Portugal, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed