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

NCT00034476 | Completed Phase 1

• 2 other identifiers: 1641J4A-MC-EZZI
• Study Type: interventional
• Target: 466
• Locations: 5 countries
• Sites: 85

Brief Summary

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.

Conditions

Sepsis

Keywords

Sepsis, sPLA2 Inhibitor

Interventions

sPLA2 Inhibitor DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (85)

Unknown Facility

Birmingham, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Unknown Facility

Berkeley, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Orange, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

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

Location

Unknown Facility

Brandon, Florida, United States

Location

Unknown Facility

Clearwater, Florida, United States

Location

Unknown Facility

Lakeland, Florida, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Augusta, Georgia, United States

Location

Unknown Facility

Chicago, Illinois, United States

Location

Unknown Facility

Oak Park, Illinois, United States

Location

Unknown Facility

Springfield, Illinois, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Des Moines, Iowa, United States

Location

Unknown Facility

Iowa City, Iowa, United States

Location

Unknown Facility

Kansas City, Kansas, United States

Location

Unknown Facility

Lexington, Kentucky, United States

Location

Unknown Facility

Lake Charles, Louisiana, United States

Location

Unknown Facility

New Orleans, Louisiana, United States

Location

Unknown Facility

Shreveport, Louisiana, United States

Location

Unknown Facility

Portland, Maine, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Springfield, Massachusetts, United States

Location

Unknown Facility

Ann Arbor, Michigan, United States

Location

Unknown Facility

Detroit, Michigan, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Saint Lous, Missouri, United States

Location

Unknown Facility

Reno, Nevada, United States

Location

Unknown Facility

East Orange, New Jersey, United States

Location

Unknown Facility

New Brunswick, New Jersey, United States

Location

Unknown Facility

Great Neck, New York, United States

Location

Unknown Facility

Manhasset, New York, United States

Location

Unknown Facility

New Hyde Park, New York, United States

Location

Unknown Facility

New York, New York, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Chapel Hill, North Carolina, United States

Location

Unknown Facility

Greensboro, North Carolina, United States

Location

Unknown Facility

Winston-Salem, North Carolina, United States

Location

Unknown Facility

Akron, Ohio, United States

Location

Unknown Facility

Toledo, Ohio, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Hershey, Pennsylvania, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Providence, Rhode Island, United States

Location

Unknown Facility

Memphis, Tennessee, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Falls Church, Virginia, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Madison, Wisconsin, United States

Location

Unknown Facility

Milwaukee, Wisconsin, United States

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Ottignies, Belgium

Location

Unknown Facility

Yvior, Belgium

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Debrecen, Hungary

Location

Unknown Facility

Debrecend, Hungary

Location

Unknown Facility

Miskolc, Hungary

Location

Unknown Facility

Pécs, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Vác, Hungary

Location

Unknown Facility

's-Hertogenbosch, Netherlands

Location

Unknown Facility

Apeldoorn, Netherlands

Location

Unknown Facility

Breda, Netherlands

Location

Unknown Facility

Groningen, Netherlands

Location

Unknown Facility

Nijmegen, Netherlands

Location

Unknown Facility

Rotterdam, Netherlands

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Krakow-Nowa Huta, Poland

Location

Unknown Facility

Poznan, Poland

Location

Unknown Facility

Sosnowiec, Poland

Location

Unknown Facility

Szczecin, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2002
• First Posted: April 30, 2002
• Study Start: October 1, 2001
• Study Completion: October 1, 2002
• Last Updated: July 19, 2006

Record last verified: 2006-07

Locations

PL (7); BE (5); HU (7); NL (6); US (60)