NCT00334828 is a Phase 3 clinical trial of eritoran tetrasodium in Severe Sepsis, sponsored by Eisai Inc..

Who is sponsoring NCT00334828?

NCT00334828 is sponsored by Eisai Inc..

What drugs are being tested in NCT00334828?

Interventions in NCT00334828: eritoran tetrasodium, Placebo.

What condition does NCT00334828 study?

NCT00334828 studies Severe Sepsis.

Is NCT00334828 still recruiting?

NCT00334828 is currently completed. Last updated 21 July 2017.

Last reviewed 2017-07-21 · How we verify

NCT00334828

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Last updated 21 July 2017

What this trial tests

Phase 3 trial testing eritoran tetrasodium in Severe Sepsis in 2,000 participants. Completed.

Timeline

1 June 2006

Primary endpoint
1 January 2011

Quick facts

Lead sponsor	Eisai Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	2,000
Start date	1 June 2006
Primary completion	1 January 2011
Sites	251 locations across United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile

Drugs / interventions tested

eritoran tetrasodium — full drug profile →
Placebo

Conditions studied

Severe Sepsis — all drugs for Severe Sepsis →

Sponsor

Eisai Inc. — full company profile →

Who can join

18 and older, any sex, with Severe Sepsis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

All-cause mortality at Day 28.
Time frame: 28 days

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Effect of eritoran, an antagonist of MD2-TLR4, on mortality in patients with severe sepsis: the ACCESS randomized trial.
Opal SM, Laterre PF, Francois B, LaRosa SP, et al · · 2013 · cited 637× · PMID 23512062 · DOI 10.1001/jama.2013.2194
The pathogenesis of sepsis.
Stearns-Kurosawa DJ, Osuchowski MF, Valentine C, Kurosawa S, et al · · 2011 · cited 441× · PMID 20887193 · DOI 10.1146/annurev-pathol-011110-130327
New insights into the immune functions of complement.
Reis ES, Mastellos DC, Hajishengallis G, Lambris JD. · · 2019 · cited 357× · PMID 31048789 · DOI 10.1038/s41577-019-0168-x
The emerging role of innate immunity in the heart and vascular system: for whom the cell tolls.
Mann DL. · · 2011 · cited 312× · PMID 21527743 · DOI 10.1161/circresaha.110.226936
Inhibition of Toll-Like Receptor Signaling as a Promising Therapy for Inflammatory Diseases: A Journey from Molecular to Nano Therapeutics.
Gao W, Xiong Y, Li Q, Yang H. · · 2017 · cited 266× · PMID 28769820 · DOI 10.3389/fphys.2017.00508
Targeting toll-like receptors: promising therapeutic strategies for the management of sepsis-associated pathology and infectious diseases.
Savva A, Roger T. · · 2013 · cited 208× · PMID 24302927 · DOI 10.3389/fimmu.2013.00387
Anti-Inflammatory Small Molecules To Treat Seizures and Epilepsy: From Bench to Bedside.
Dey A, Kang X, Qiu J, Du Y, et al · · 2016 · cited 161× · PMID 27062228 · DOI 10.1016/j.tips.2016.03.001
Eritoran tetrasodium (E5564) treatment for sepsis: review of preclinical and clinical studies.
Barochia A, Solomon S, Cui X, Natanson C, et al · · 2011 · cited 141× · PMID 21323610 · DOI 10.1517/17425255.2011.558190

Verify or expand the search:

Other recruiting trials for Severe Sepsis

Currently open trials in the same condition.

NCT06143137 — Recovery From Acute Immune Failure in Septic Shock by Immune Cell Extracorporeal Therapy - Observational Long-term Outco · recruiting
NCT04955210 — A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children · recruiting
NCT05413343 — Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients · active not recruiting

Other Eisai Inc. trials

Trials by the same sponsor.

NCT07493265 — A Study to Evaluate the Efficacy and Safety of E2086 in Adults With Narcolepsy · Phase 2 · not yet recruiting
NCT07308236 — A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants · Phase 1 · recruiting
NCT06854042 — A Study of Oral E1018 in Healthy Adult Participants · Phase 1 · recruiting
NCT06744673 — A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control P · active not recruiting
NCT06602258 — A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease · Phase 2 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00334828 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Eisai Inc.
Last refreshed: 21 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00334828.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing