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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.

Criteria

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