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

Phase 3

Completed

• Conditions: Severe Sepsis
• Interventions: Drug: Placebo; Drug: eritoran tetrasodium

• Registration Number: NCT00334828
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-06-06
• Study First Submitted QC: 2006-06-06
• Study First Posted: 2006-06-08
• Primary Completion: 2011-01
• Disposition First Submitted: 2013-05-21
• Disposition First Submitted QC: 2013-05-21
• Disposition First Posted: 2013-05-29
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-21
• Last Update Posted: 2017-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	eritoran tetrasodium	-

Primary Outcome Measures

Name	Time	Method
All-cause mortality at Day 28.	28 days