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

July 18, 2006 updated by: Eli Lilly and Company

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

Intervention / Treatment

Study Type

Interventional

Enrollment

466

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1641
  • J4A-MC-EZZI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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