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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00334828




Registration number
NCT00334828
Ethics application status
Date submitted
6/06/2006
Date registered
8/06/2006
Date last updated
25/07/2017

Titles & IDs
Public title
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
Scientific title
ACCESS: A Controlled Comparison of Eritoran Tetrasodium and Placebo in Patients With Severe Sepsis
Secondary ID [1] 0 0
2005-005537-35
Secondary ID [2] 0 0
E5564-G000-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Sepsis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - eritoran tetrasodium
Treatment: Drugs - Placebo

Experimental: 1 -

Placebo comparator: 2 -


Treatment: Drugs: eritoran tetrasodium
Intravenous infusion at a total dose of 105 mg.

Treatment: Drugs: Placebo
Matching placebo; intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All-cause mortality at Day 28.
Timepoint [1] 0 0
28 days

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
2000
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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- St. Leonards
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- Westmead
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- Southport
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- Adelaide
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- Woodville
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- Heidelberg
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- Melbourne
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- Parkville
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- Nedlands
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- Perth
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- Box Hill
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- New South Wales
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- Queensland
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- St. Leonards
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- Westmead
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- Southport
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- Adelaide
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- Woodville
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- Heidelberg
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- Perth
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- Box Hill
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- New South Wales
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- Queensland
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00334828
Trial related presentations / publications
Opal SM, Laterre PF, Francois B, LaRosa SP, Angus DC, Mira JP, Wittebole X, Dugernier T, Perrotin D, Tidswell M, Jauregui L, Krell K, Pachl J, Takahashi T, Peckelsen C, Cordasco E, Chang CS, Oeyen S, Aikawa N, Maruyama T, Schein R, Kalil AC, Van Nuffelen M, Lynn M, Rossignol DP, Gogate J, Roberts MB, Wheeler JL, Vincent JL; ACCESS Study Group. Effect of eritoran, an antagonist of MD2-TLR4, on mortality in patients with severe sepsis: the ACCESS randomized trial. JAMA. 2013 Mar 20;309(11):1154-62. doi: 10.1001/jama.2013.2194.
Public notes

Contacts
Principal investigator
Name 0 0
Dan Rossignol
Address 0 0
Eisai Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00334828