ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
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.
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:
New South Wales, New South Wales, Australia
Queensland, Queensland, Australia
Curitba, Brazil
Fontaleza, Brazil
Plyzen, Czechia
Evry Courcouronnes, France
Yotsukaidou, Japan
s'Hertogenbosch, Netherlands
Groszisk Mazowiecki, Poland
Alcala de Henares Madrid, Spain
Cataluna, Spain
Yung Kang City, Taiwan