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

NCT ID: NCT00034476

Last Updated: 2006-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

466 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2002-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis

Keywords

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Sepsis, sPLA2 Inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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sPLA2 Inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Locations

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Berkeley, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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San Diego, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Washington D.C., District of Columbia, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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Lakeland, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Oak Park, Illinois, United States

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Springfield, Illinois, United States

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Indianapolis, Indiana, United States

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Des Moines, Iowa, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Lake Charles, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Portland, Maine, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Saint 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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New Brunswick, New Jersey, United States

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Great Neck, New York, United States

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Manhasset, New York, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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The Bronx, New York, United States

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Chapel Hill, North Carolina, United States

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Greensboro, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Toledo, Ohio, United States

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Portland, Oregon, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Memphis, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Falls Church, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Brussels, , Belgium

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Ghent, , Belgium

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Liège, , Belgium

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Ottignies, , Belgium

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Yvior, , Belgium

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Budapest, , Hungary

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Debrecen, , Hungary

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Debrecend, , Hungary

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Miskolc, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Vác, , Hungary

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's-Hertogenbosch, , Netherlands

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Apeldoorn, , Netherlands

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Breda, , Netherlands

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Groningen, , Netherlands

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Gdansk, , Poland

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Krakow-Nowa Huta, , Poland

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Poznan, , Poland

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Sosnowiec, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Countries

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United States Belgium Hungary Netherlands Poland

Other Identifiers

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J4A-MC-EZZI

Identifier Type: -

Identifier Source: secondary_id

1641

Identifier Type: -

Identifier Source: org_study_id