A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00034476
Recruitment Status : Completed
First Posted : April 30, 2002
Last Update Posted : July 19, 2006
Information provided by:
Eli Lilly and Company

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: sPLA2 Inhibitor Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 466 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
Study Start Date : October 2001
Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Patients must

  • show evidence of acute infection
  • meet specified time windows
  • be 18 years of age or older

Exclusion Criteria: Patients must not

  • have low white blood cell count
  • have undergone certain organ transplants
  • be HIV positive
  • be pregnant or breast feeding
  • have severe underlying medical problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00034476

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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Berkeley, California, United States
Los Angeles, California, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Lake Charles, Louisiana, United States
New Orleans, Louisiana, United States
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United States, Maine
Portland, Maine, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
Springfield, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
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Minneapolis, Minnesota, United States
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St. Lous, Missouri, United States
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Reno, Nevada, United States
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East Orange, New Jersey, United States
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United States, New York
Bronx, New York, United States
Great Neck, New York, United States
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Hershey, Pennsylvania, United States
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Debrecen, Hungary
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Szeged, Hungary
Vac, Hungary
Apeldoorn, Netherlands
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Rotterdam, Netherlands
Gdansk, Poland
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Poznan, Poland
Sosnowiec, Poland
Szczecin, Poland
Warsaw, Poland
Warszawa, Poland
Wroclaw, Poland
Sponsors and Collaborators
Eli Lilly and Company Identifier: NCT00034476     History of Changes
Other Study ID Numbers: 1641
First Posted: April 30, 2002    Key Record Dates
Last Update Posted: July 19, 2006
Last Verified: July 2006

Keywords provided by Eli Lilly and Company:
Sepsis, sPLA2 Inhibitor

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes