Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eisai Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
