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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00034476
First received: April 29, 2002
Last updated: July 18, 2006
Last verified: July 2006
  Purpose

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 Intervention Phase
Sepsis
Drug: sPLA2 Inhibitor
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Estimated Enrollment: 466
Study Start Date: October 2001
Estimated Study Completion Date: October 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034476

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Berkeley, California, United States
Los Angeles, California, United States
Orange, California, United States
San Diego, California, United States
Torrance, California, United States
United States, Colorado
Denver, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Brandon, Florida, United States
Clearwater, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
United States, Georgia
Augusta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
Oak Park, Illinois, United States
Springfield, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Iowa
Des Moines, Iowa, United States
Iowa, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Kentucky
Lexington, Kentucky, United States
United States, Louisiana
Lake Charles, Louisiana, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maine
Portland, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Missouri
St. Lous, Missouri, United States
United States, Nevada
Reno, Nevada, United States
United States, New Jersey
East Orange, New Jersey, United States
New Brunswick, New Jersey, United States
United States, New York
Bronx, New York, United States
Great Neck, New York, United States
Manhasset, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
Greensboro, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Toledo, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburg, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Tennessee
Memphis, Tennessee, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
United States, Virginia
Falls Church, Virginia, United States
United States, Washington
Seattle, Washington, United States
United States, Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Belgium
Brussels, Belgium
Bruxelles, Belgium
Gent, Belgium
Liege, Belgium
Ottignies, Belgium
Yvior, Belgium
Hungary
Budapest, Hungary
Debrecen, Hungary
Debrecend, Hungary
Miskolc, Hungary
Pecs, Hungary
Szeged, Hungary
Vac, Hungary
Netherlands
Apeldoorn, Netherlands
Breda, Netherlands
Den Bosch, Netherlands
Groningen, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Poland
Gdansk, Poland
Krakow-Nowa Huta, Poland
Poznan, Poland
Sosnowiec, Poland
Szczecin, Poland
Warsaw, Poland
Warszawa, Poland
Wroclaw, Poland
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00034476     History of Changes
Other Study ID Numbers: 1641, J4A-MC-EZZI
Study First Received: April 29, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014