ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis

Completed · Phase 3 · Has a placebo group

Conditions studied: Severe Sepsis

In brief

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.

Key facts

Study ID

NCT00334828

Run by

Eisai Inc.

People needed

2000

Starts

2006-06-01

Last updated by the study team

2017-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Loma Linda, California, United States
• Study site — Marysville, California, United States
• Study site — Orange, California, United States
• Study site — San Diego, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Denver, Colorado, United States
• Study site — New Haven, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Atlantis, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Pensacola, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Idaho Falls, Idaho, United States
• Study site — Chicago, Illinois, United States
• Study site — Oak Park, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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