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

Study Overview
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Brief Summary
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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.

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

Conditions
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Severe Sepsis

Intervention / Treatment
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* Drug: eritoran tetrasodium
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: eritoran tetrasodium<br>* Intravenous infusion at a total dose of 105 mg.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Matching placebo; intravenous infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality at Day 28. |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe sepsis, septic shock, sepsis