ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis - Full Text View

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

This study is currently recruiting participants.
Verified by Eisai Medical Research Inc., August 2008

Sponsored by:	Eisai Medical Research Inc.
Information provided by:	Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00334828

Purpose

This is a randomized, double-blind, placebo-controlled study. Recruitment will be from approximately 250 sites in the US, Canada, EU, IL, AU/NZ, South Africa, Chile, Argentina, Brazil, Mexico and Japan. Subjects will be randomly assigned to one of two treatment groups (eritoran or placebo administered every 12 hours for a total of 11 doses) after a baseline assessment.

Condition	Intervention	Phase
Severe Sepsis	Drug: SGEA Drug: Placebo	Phase III

MedlinePlus related topics:

Sepsis

ChemIDplus related topics:

Eritoran

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Eisai Medical Research Inc.:

Primary Outcome Measures:

Survival at Day 28. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	2000
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: SGEA Intravenous injection; 105 mg.
2: Placebo Comparator	Drug: Placebo Intravenous injection; 105 mg.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

INCLUSION CRITERIA:

Age >= 18 years
Confirmed early onset severe sepsis, defined as:
- Objective evidence of infection likely to be caused by a bacterial or fungal pathogen.
- Presence of at least 3 of 4 SIRS criteria
- Sepsis-associated organ dysfunction
- Baseline Apache II Score of 21 to 37
< 12 hour between onset of the first qualifying organ dysfunction and expected administration of study drug
A commitment to full patient support

EXCLUSION CRITERIA:

Pregnancy
Extensive (>20% BSA) 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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334828

Contacts


Contact: Eisai Medical Services	1-888-422-4743

Show 184 Study Locations

Sponsors and Collaborators

Eisai Medical Research Inc.

Investigators


Study Director:	Alec Wittek, M.D.	Eisai Medical Research Inc.

More Information

Responsible Party:	Eisai Medical Research Inc. ( Alec Wittek, M.D., Study Director )
Study ID Numbers:	E5564-G000-301
First Received:	June 6, 2006
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00334828
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Systemic Inflammatory Response Syndrome

Sepsis

Inflammation

Additional relevant MeSH terms:

Pathologic Processes

Infection

ClinicalTrials.gov processed this record on October 14, 2008