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

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 Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Drug: sPLA2 Inhibitor

• Study Type: Interventional
• Enrollment: 466
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• 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
• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arizona
    • Phoenix, Arizona, 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
  • Colorado
    • Denver, Colorado, United States
  • District of Columbia
    • Washington, District of Columbia, 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
  • Georgia
    • Augusta, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
    • Oak Park, Illinois, United States
    • Springfield, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Iowa
    • Des Moines, Iowa, United States
    • Iowa, 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
    • Ann Arbor, Michigan, United States
    • Detroit, 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
    • Great Neck, New York, United States
    • Manhasset, New York, United States
    • New Hyde Park, New York, United States
    • New York, New York, United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
    • Greensboro, North Carolina, United States
    • Winston-Salem, North Carolina, United States
  • Ohio
    • Akron, Ohio, United States
    • Toledo, Ohio, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
    • Pittsburg, 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Study Completion: October 1, 2002

Study Registration Dates

• First Submitted: April 29, 2002
• First Submitted That Met QC Criteria: April 29, 2002
• First Posted (Estimate): April 30, 2002

Study Record Updates

• Last Update Posted (Estimate): July 19, 2006
• Last Update Submitted That Met QC Criteria: July 18, 2006
• Last Verified: July 1, 2006

More Information

Terms related to this study

• Keywords: Sepsis, sPLA2 Inhibitor
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: 1641; J4A-MC-EZZI