SepsisPhase 2NCT00046072
A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis
A Phase 2 study testing E5564 in people with Sepsis and Shock, Septic, run by Eisai Inc. at 17 sites in United States.
Trial summary
Sepsis is a serious condition where there is inflammation and damage to body tissue, usually caused by an infection. This infection can lead to decreased function of vital body organs and in some cases may lead to permanent health problems or death. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sepsis, Shock, Septic, Sepsis Syndrome
- What is being tested?
- E5564
- How many people
- 300 participants
- Where
- 17 sitesUnited States
- Study dates
- Oct 2001to Apr 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presently admitted, or about to be transferred, to the ICU.
- Women of Child-bearing potential must have a negative serum (or urine) hCG assay within 24 hours prior to drug administration.
- Any Race.
- Severe Sepsis [newly developed respiratory failure, refractory shock, renal dysfunction, hepatic dysfunction, or metabolic acidosis and at least three signs of SIRS (systematic inflammatory response syndrome)].
- Objective signs of infection likely to be caused by a bacterial or fungal pathogen.
- Patients must receive study medication within 8 to 12 hours of recognition of the initial sepsis-related organ failure.
- APACHE Predicted risk of mortality score between 20% and 80%.
- An intent by physicians and family to aggressively treat the patient for the 28 day study period.
Who cannot join
- Cardiogenic or hypovolemic shock.
- Acute third degree burns involving >20% of body surface.
- Recipients of non-autologous organ transplants within the past year.
- Pregnancy.
- Chronic vegetative state.
- Uncontrolled serious hemorrhage (.2 units of blood/platelets in the previous 24 hours). Patients may be considered for enrollment if bleeding has stopped and patients are still otherwise qualified.
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- Unwilling or unable to be fully evaluated for all follow-up visits.
- Patients who are classified as "Do not resusitate" or "Do not treat."
- Patients who develop severe sepsis <36 hours post trauma or post-surgery. Patients may be considered for enrollment >36 hours post-trauma or post-surgery, if they meet other inclusion criteria.
- Patients with a predicted risk of mortality score of <20% or >80% after recognition of qualifying organ failure.
- Patients with a predicted risk of mortality of <51% for whom Xigris® use is planned.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Study site
Boston, Massachusetts, 02114
Study site
Buffalo, New York, 14203
Study site
Columbus, Georgia, 31902
Study site
Dallas, Texas, 75390
Study site
Elk Grove, Illinois, 60007
Study site
Galveston, Texas, 77555
Study site
Jacksonville, Florida, 32209
Study site
Kansas City, Kansas, 66160
Study site
Manhasset, New York, 11030
Study site
Miami, Florida, 33125
Study site
Mobile, Alabama, 36608
Study site
Oklahoma City, Oklahoma, 73104
Study site
Pensacola, Florida, 32504
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92134
Study site
Santa Barbara, California, 93105
Study site
Springfield, Massachusetts, 01199
About this study
Official title: A Double-Blind, Placebo-Controlled Study of E5564, A Lipid A Antagonist, Administered by Twice Daily Infusions in Patients With Severe Sepsis
Sepsis is a serious condition where there is inflammation and damage to body tissue, usually caused by an infection. This infection can lead to decreased function of vital body organs and in some cases may lead to permanent health problems or death.
Much of the injury is due to endotoxin, a harmful substance produced by certain types of bacteria. An endotoxin antagonist is designed to block the effects of endotoxin.
This study is designed to study the safety and efficacy when treating patients with severe sepsis.
- Conditions
- Sepsis, Shock, Septic, Sepsis Syndrome, Septicemia, Infection
- Being tested
- E5564
- Keywords
- Sepsis, Shock, Septic, Sepsis Syndrome, Septicemia, Endotoxins, Endotoxemia, Infection
- Medical subject headings
- Sepsis, Shock, Septic, Systemic Inflammatory Response Syndrome, Infections, Shock, Endotoxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E5564Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2002 (estimated)
- Study startOct 2001
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alec Wittek, M.D., Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00046072
- Sponsor's protocol ID
- E5564-A001-201
- Status last verified
- Dec 2005
- First submitted
- 19 Sep 2002
- Last updated
- 12 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of E5564, A Lipid A Antagonist, Administered by Twice Daily Infusions in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT00046072
- Acronym / sponsor ID
- E5564-A001-201
- Conditions
- Sepsis, Shock, Septic, Sepsis Syndrome, Septicemia, Infection
- Keywords
- Sepsis, Shock, Septic, Sepsis Syndrome, Septicemia, Endotoxins, Endotoxemia, Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Apr 2005
- First posted
- 20 Sep 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis is a serious condition where there is inflammation and damage to body tissue, usually caused by an infection. This infection can lead to decreased function of vital body organs and in some cases may lead to permanent health problems or death.
Much of the injury is due to endotoxin, a harmful substance produced by certain types of bacteria. An endotoxin antagonist is designed to block the effects of endotoxin.
This study is designed to study the safety and efficacy when treating patients with severe sepsis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Presently admitted, or about to be transferred, to the ICU.
- Women of Child-bearing potential must have a negative serum (or urine) hCG assay within 24 hours prior to drug administration.
- Any Race.
- Severe Sepsis [newly developed respiratory failure, refractory shock, renal dysfunction, hepatic dysfunction, or metabolic acidosis and at least three signs of SIRS (systematic inflammatory response syndrome)].
- Objective signs of infection likely to be caused by a bacterial or fungal pathogen.
Key exclusion criteria (11 listed)
- Cardiogenic or hypovolemic shock.
- Acute third degree burns involving >20% of body surface.
- Recipients of non-autologous organ transplants within the past year.
- Pregnancy.
- Chronic vegetative state.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E5564 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2005.
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alec Wittek, M.D. study director
Eisai Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E5564 in people with Sepsis and Shock, Septic, run by Eisai Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2005; AzTrials last refreshed its copy on 7 Nov 2026.