SepsisPhase 1/2NCT00034476
A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
A Phase 1/2 study testing sPLA2 Inhibitor in people with Sepsis, run by Eli Lilly and Company at 85 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- sPLA2 Inhibitor
- How many people
- 466 participants
- Where
- 85 sitesin 5 countries
- Study dates
- Oct 2001to Oct 2002
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- show evidence of acute infection
- meet specified time windows
- be 18 years of age or older
Who cannot join
- have low white blood cell count
- have undergone certain organ transplants
- be HIV positive
- be pregnant or breast feeding
- have severe underlying medical problems
Trial locations and contacts
85 sites in 5 countries.
85 sites in 5 countries
United States60 sites
Study site
Akron, Ohio
Study site
Ann Arbor, Michigan
Study site
Augusta, Georgia
Study site
Baltimore, Maryland
Study site
Berkeley, California
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Brandon, Florida
Study site
Chapel Hill, North Carolina
Study site
Chicago, Illinois
Study site
Clearwater, Florida
Study site
Denver, Colorado
Study site
Des Moines, Iowa
Study site
Detroit, Michigan
Study site
East Orange, New Jersey
Study site
Falls Church, Virginia
Study site
Great Neck, New York
Study site
Greensboro, North Carolina
Study site
Hershey, Pennsylvania
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Iowa City, Iowa
Study site
Kansas City, Kansas
Study site
Lake Charles, Louisiana
Study site
Lakeland, Florida
Study site
Lexington, Kentucky
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Manhasset, New York
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Milwaukee, Wisconsin
Study site
Minneapolis, Minnesota
Study site
New Brunswick, New Jersey
Study site
New Hyde Park, New York
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Oak Park, Illinois
Study site
Orange, California
Study site
Orlando, Florida
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Maine
Study site
Portland, Oregon
Study site
Providence, Rhode Island
Study site
Reno, Nevada
Study site
Saint Lous, Missouri
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Seattle, Washington
Study site
Shreveport, Louisiana
Study site
Springfield, Illinois
Study site
Springfield, Massachusetts
Study site
Tampa, Florida
Study site
The Bronx, New York
Study site
Toledo, Ohio
Study site
Torrance, California
Study site
Washington D.C., District of Columbia
Study site
Winston-Salem, North Carolina
Hungary7 sites
Study site
Budapest
Study site
Debrecen
Study site
Debrecend
Study site
Miskolc
Study site
Pécs
Study site
Szeged
Study site
Vác
Poland7 sites
Study site
Gdansk
Study site
Krakow-Nowa Huta
Study site
Poznan
Study site
Sosnowiec
Study site
Szczecin
Study site
Warsaw
Study site
Wroclaw
Netherlands6 sites
Study site
's-Hertogenbosch
Study site
Apeldoorn
Study site
Breda
Study site
Groningen
Study site
Nijmegen
Study site
Rotterdam
Belgium5 sites
Study site
Brussels
Study site
Ghent
Study site
Liège
Study site
Ottignies
Study site
Yvior
About this study
The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins.
The study drug is an investigational drug that is still in development. It has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. Patient participation in this study will last for about one month.
- Conditions
- Sepsis
- Being tested
- sPLA2 Inhibitor
- Keywords
- Sepsis, sPLA2 Inhibitor
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sPLA2 InhibitorDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2002 (estimated)
- Study startOct 2001
- Study completionOct 2002
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 Eli Lilly and CompanyThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 466 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034476
- Sponsor's protocol ID
- 1641
- Other IDs
- J4A-MC-EZZI
- Status last verified
- Jul 2006
- First submitted
- 29 Apr 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT00034476
- Acronym / sponsor ID
- 1641
- Conditions
- Sepsis
- Keywords
- Sepsis, sPLA2 Inhibitor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 466 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Oct 2002
- First posted
- 30 Apr 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.
The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins.
The study drug is an investigational drug that is still in development. It has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. Patient participation in this study will last for about one month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- show evidence of acute infection
- meet specified time windows
- be 18 years of age or older
Key exclusion criteria (5 listed)
- have low white blood cell count
- have undergone certain organ transplants
- be HIV positive
- be pregnant or breast feeding
- have severe underlying medical problems
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 |
|---|---|---|
| sPLA2 Inhibitor | 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 19 Jul 2006.
Related trials for Sepsis
Not yet recruitingObservational study
Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
Sepsis, Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
85 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing sPLA2 Inhibitor in people with Sepsis, run by Eli Lilly and Company at 85 sites in 5 countries.
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 3 inclusion and 5 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 19 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States, Hungary, Poland, Netherlands, Belgium. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 19 Jul 2006.