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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334828
• Other study ID #: E5564-G000-301
• Secondary ID: 2005-005537-35
• Status: Completed
• Phase: Phase 3
• First received: June 6, 2006
• Last updated: July 21, 2017
• Start date: June 2006

Study information

• Verified date: July 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

Drug:
• eritoran tetrasodium
Intravenous infusion at a total dose of 105 mg.
• Placebo
Matching placebo; intravenous infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Czechia,  France,  Germany,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Portugal,  South Africa,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality at Day 28.		28 days

External Links

•   Link to EUCTR results