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	Treatment or Intervention	Phase
Sepsis	Drug: sPLA2 Inhibitor	Phase I Phase II

Further Study Details: 

Expected Total Enrollment:  466

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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

Study ID Numbers:  1641
Record last reviewed:  April 2002
Last Updated:  October 13, 2004
Record first received:  April 29, 2002
ClinicalTrials.gov Identifier:  NCT00034476
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08