SepsisPhase 4NCT00045760

The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients With Severe Sepsis

A Phase 4 study testing Drotrecogin alfa (activated) in people with Sepsis, run by Eli Lilly and Company at 426 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Severe sepsis is defined as a systemic inflammatory response syndrome that results from infection and is associated with acute organ dysfunction. It usually results from bacterial infections, but it may occur in response to other pathogens, such as fungi, viruses, and parasites. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis
What is being tested?: Drotrecogin alfa (activated)
How many people: Not given
Where: 426 sitesin 32 countries
Study dates: Sep 2002to not given
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients with severe sepsis.
Presence of a suspected or proven infection.
One or more sepsis-associated organ failure.

Who cannot join

Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country.
Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
Platelet count <30,000/mm3.
Are receiving therapeutic heparin.

Trial locations and contacts

426 sites in 32 countries.

Country

City, postcode or hospital

426 sites in 32 countries

United States152 sites

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Abington, Pennsylvania
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Akron, Ohio
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Albany, Georgia
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Albany, New York
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Albuquerque, New Mexico
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Alexandria, Virginia
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Allentown, Pennsylvania
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Anaheim, California
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Atlanta, Georgia
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Augusta, Georgia
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Austell, Georgia
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Austin, Texas
timoreFor additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Baltimore, Maryland
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Barrien Springs, Michigan
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Berkeley, California
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Berwyn, Illinois
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Bethesda, Maryland
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Bismarck, North Dakota
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Boston, Massachusetts
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Brandon, Florida
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Buffalo, New York
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Burbank, California
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Charlotte, North Carolina
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Charlottesville, Virginia
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Chattanoga, Tennessee
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Chicago, Illinois
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Cincinnati, Ohio
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City of Saint Peters, Missouri
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Clearwater, Florida
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Cleveland, Ohio
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Colorado Springs, Colorado
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Columbus, Ohio
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Corpus Christi, Texas
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Covington, Louisiana
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Crestview Hills, Kentucky
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Dallas, Texas
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Danville, Pennsylvania
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Dayton, Ohio
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Decatur, Illinois
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Denver, Colorado
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Des Moines, Iowa
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Detroit, Michigan
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East Meadow, New York
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East Stroudsburg, Pennsylvania
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El Paso, Texas
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Elk Grove, Illinois
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Englewood, Colorado
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Erie, Pennsylvania
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Everett, Washington
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Fort Lauderdale, Florida
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Fort Sam Houston, Texas
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Fort Wayne, Indiana
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Forth Worth, Texas
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Fullerton, California
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Gainesville, Florida
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Galveston, Texas
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Grand Rapids, Michigan
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Greensboro, North Carolina
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Greenville, South Carolina
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Hackensack, New Jersey
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Hendersonville, North Carolina
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Honolulu, Hawaii
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Houston, Texas
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Huntington, West Virginia
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Idaho Falls, Idaho
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Indianapolis, Indiana
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Irving, Texas
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Jackson, Mississippi
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Jackson, Tennessee
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Jacksonville, Florida
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Jefferson Hills, Pennsylvania
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Johnson City, New York
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Jonesboro, Arkansas
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Kansas City, Kansas
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Knoxville, Tennessee
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La Jolla, California
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Lackland Air Force Base, Texas
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Lake Charles, Louisiana
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Lakeland, Florida
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Larchmont, New York
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Lincoln, Nebraska
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Little Rock, Arkansas
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Loma Linda, California
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Long Beach, California
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Loveland, Colorado
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Lynchburg, Virginia
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Macon, Georgia
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Manfield, Ohio
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Manhasset, New York
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Marietta, Georgia
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Memphis, Tennessee
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Miami, Florida
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Milford, Connecticut
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Milwaukee, Wisconsin
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Missoula, Montana
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Mobile, Alabama
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Morgantown, West Virginia
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Nashville, Tennessee
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Neptune City, New Jersey
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New Albany, Indiana
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New Haven, Connecticut
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New Hyde Park, New York
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New York, New York
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Oak Park, Illinois
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Oakland, California
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Odessa, Texas
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Oklahoma City, Oklahoma
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Olathe, Kansas
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Omaha, Nebraska
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Palm Springs, California
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Philadelphia, Pennsylvania
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Phillipsburg, New Jersey
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Plantation, Florida
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Portland, Maine
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Rapid City, South Dakota
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Reading, Pennsylvania
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Riverdale, Georgia
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Riverside, California
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Rochester, New York
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Royal Oak, Michigan
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Sacramento, California
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Saint Paul, Minnesota
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Salt Lake City, Utah
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San Diego, California
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San Francisco, California
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Santa Barbara, California
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Sarasota, Florida
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Savannah, Georgia
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Sayre, Pennsylvania
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Scottsdale, Arizona
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Sioux Falls, South Dakota
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Springfield, Illinois
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Springfield, Massachusetts
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St Louis, Missouri
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St. Petersburg, Florida
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Stamford, Connecticut
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Stanford, California
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Syracuse, New York
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Tamarac, Florida
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Tampa, Florida
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The Bronx, New York
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Tulsa, Oklahoma
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Tuscon, Arizona
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Washington D.C., District of Columbia
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Weston, Florida
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York, Pennsylvania
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Youngstown, Ohio
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Ypsilanti, Michigan

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For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Aulnay-sous-Bois, Aulnay-Sous-Bois
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Besançon, Besancon Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Bondy, Bondy Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Clichy, Clichy
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Corbeil-Essonnes, Corbeil Essonnes Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Dijon, Dijon Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Garches
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Gleizé, Gleize
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Le Chesnay, Le Chesnay Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Le Kremlin-Bicêtre, Le Kremlin Bicetre Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Lille, Lille Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Lille, Lille
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Limoges, Limoges Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Longsumeau Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Lyon, Lyon Cedex 03
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Marseille, Marseille Cedex 09
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Nancy, Nancy
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Nice, Nice Cedex 1
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Nice, Nice Cedex 3
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Nîmes, Nimes
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Orléans, Orleans Cedex 2
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Paris, Paris Cedex 10
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Paris, Paris Cedex 13
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Paris, Paris Cedex 14
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Poissy, Poissy
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Poitiers, Poitiers
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Pontoise, Pontoise Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Rennes
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Saint-Denis, Saint Denis Cedex 1
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Saint-Etienne, Saint Etienne Cedex 2
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Strasbourg, Strasbourg Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Toulouse, Toulouse
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Tours, Tours Cedex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Vesoul, Vesoul

Other trials in France

Italy32 sites

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Ancona, Ancona
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Arezzo, Arezzo
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Arzignano, Vicenza
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Bergamo, Bergamo
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Bologna, Bologna
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Bolzano, Bolzano
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Cagliari, Cagliari
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Carbonara, Bari
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Catania, CT
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Como, Como
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Ferrara, Ferrara
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Genova
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Lecce, Lecce
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Lecco, Lecco
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Milan, Milano
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Monza, MI
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Padova, Padova
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Palermo, Palermo
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Palermo
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Pavia, Pavia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Pesaro, Pesaro
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Pietra Ligure, Savona
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Pisa, Pisa
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Pordenone, PD
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Roma, roma
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Sassari, sassari
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Siena, Siena
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Treviglio, Treviglio
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Trieste, Trieste
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Varese, Varese
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Vicenza, Vicenza
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Vimercate, Milano

Other trials in Italy

Spain27 sites

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Alcorcón, Madrid
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Alicante, Alicante
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Badajoz, Badajoz
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Barcelona, Barcelona
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Burgos, Burgos
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Cadiz, Cadiz
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Castellon, Castellon
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Galdakao, Vizcaya
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Getafe, Madrid
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Girona, Barcelona
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Jerez de la Frontera, Cadiz
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Las Palmas, Gran Canaria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Leganés, Madrid
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Madrid, Madrid
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Murcia, Murcia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Palencia, Palencia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Palma de Mallorca, Palma de Mallorca
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Sabadell, Barcelona
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Salmanca, Salmanca
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
San Juan, Alicante
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Santa Cruz de Tenerife, Santa Cruz De Tenerife
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Santander, Cantabria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Santiago Compostela, La Coruna
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Seville, Sevilla
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Terrassa
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Valencia, Valencia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Valladolid, Valladolid

Other trials in Spain

United Kingdom25 sites

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Aberdeen, Scotland
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Birmingham, West Midlands
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Bradford, Bradford
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Cambridge, Cambridgeshire
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Cardiff, Cardiff
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Guildford, Surrey
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Harrow, Middlesex
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Kings Lynn, Norfolk
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Langside, Glasgow
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Leeds, West Yorkshire
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Leicester, Leicestershire
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Livingstone, West Lothian
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
London, London
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
London, London
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Manchester, Lancashire
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Northampton, Northampton
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Norwich, Norfolk
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Nottingham, Nottinghamshire
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Plymouth, Devon
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Portsmouth, Hampshire
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Reading, London Road
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Royal Tunbridge Wells, Kent
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Southampton, Hants
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Waterloo, London
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Wythenshawe, Manchester

Other trials in United Kingdom

Australia21 sites

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Adelaide, South Australia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Bedford Park, South Australia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Box Hill, Victoria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Camperdown, New South Wales
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Dandenong, Victoria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Douglas, Queensland
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Fitzroy, Victoria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Footscray, Victoria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Garran, Australian Capital Territory
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Heidelberg, Victoria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Herston, Queensland
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Hobart, Tasmania
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Kingswood, New South Wales
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Liverpool, New South Wales
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Nedlands, Western Australia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Parkville, Victoria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Perth, Western Australia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Prahran, Victoria
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Randwick, New South Wales
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
St Leonards, New South Wales
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Tiwi, Northern Territory

Other trials in Australia

Canada20 sites

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Brampton, Ontario
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Calgary, Alberta
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Edmonton, Alberta
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Greater Sudbury, Ontario
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Greenfield Park, Quebec
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Halifax, Nova Scotia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Hamilton, Ontario
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Kingston, Ontario
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
London, Ontario
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Montreal, Quebec
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
New Westminster, British Columbia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Ottawa, Ontario
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Regina, Saskatchewan
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Saint John, New Brunswick
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Saskatoon, Saskatchewan
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Sherbrooke, Quebec
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Toronto, Ontario
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Vancouver, British Columbia
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician.
Windsor, Ontario
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Winnipeg, Manitoba

Other trials in Canada

Germany18 sites

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Aachen, Aachen
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Berlin, State of Berlin
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Bonn, Bonn
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Bremen, Free Hanseatic City of Bremen
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Erfurt, Erfurt
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Essen, Hesse
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Freiburg im Breisgau, Freiburg
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Göttingen
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Halle, Halle
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Hamburg, Free and Hanseatic City of Hamburg
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Hanover, Hannover
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Leipzig, Leipzig
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Lübeck, Lubeck
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Mannheim, Mannheim
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München, Munchen
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Regensburg, Regensburg
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Reutlingen, Reutlingen
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Tübingen, Tubingen

Other trials in Germany

Brazil9 sites

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Curitiba, Paraná
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Florianópolis, Santa Catarina
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Porto Alegre, Porto Alegre
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Porto Alegre
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Rio de Janeiro, Rio de Janeiro
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Rio de Janeiro, Rio de Janeiro
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Salvador, Estado de Bahia
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São Paulo, São Paulo
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São Paulo, São Paulo

Other trials in Brazil

Czechia9 sites

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Brno, Brno
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Hradec Králové, Hradec Kralove
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Olomouc, Olomouc
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Ostrava Poruba, Ostrava Poruba
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Pilsen, Plzen
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Prague, Praha 10
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Prague, Praha 2
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Prague, Praha 8
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Praha 5 Motol, Praha 5 Motol

Other trials in Czechia

Sweden9 sites

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Falun, Falun
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Gothenburg, Goteborg
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Huddinge, Huddinge
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Karistad
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Kristianstad, Kristianstad
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Östersund, Ostersund
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Skövde
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Stockholm, Stockholm County
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Sundsvall, Sundsvall

Other trials in Sweden

Belgium7 sites

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Brussells, Brussells
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Brussels, Brussels Capital
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Ghent, Gent
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Liège, Liege
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Mons, Mons
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Ottignies, Ottignies
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Yvior, Yvior

Other trials in Belgium

India7 sites

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Bangalore, Karnataka
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Hyderabad, Andhara Pradesh
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Hyderabad, Hyderabad
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Mumbai, Maharashtra
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New Delhi, National Capital Territory of Delhi
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Noida, Uttar Pradesh
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Pune, Maharashtra

Other trials in India

South Africa7 sites

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Bloemfontein, Bloemfontein
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Cape Town
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Kimberley, Northern Cape
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Medunsa
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Pretoria, Pretoria
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Somerset West, Cape Province
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Thaba Tshwane, Thaba Tshwane

Other trials in South Africa

Finland6 sites

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Helsinki, Hus, Helsinki, Hus
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Jyväskylä, Jyvaskyla
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Kuopio, Kuopio
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Oulu, Oulu
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Tampere
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Turku, Turku

Other trials in Finland

Norway5 sites

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Ålesund, Alesund
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Drammen, Drammen
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Nordbyhagen, Nordbyhagen
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Oslo, Oslo
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Trondheim, Trondheim

Other trials in Norway

Denmark4 sites

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Esbjerg, Esbjerg
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Hvidovre, Hvidovre
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Roskilde, Roskilde
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Viborg, Viborg

Other trials in Denmark

Netherlands4 sites

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's-Hertogenbosch, Den Bosch
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Apeldoorn, Apeldoorn
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Breda, Breda
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Tilburg, Tilburg

Other trials in Netherlands

New Zealand4 sites

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Auckland, Auckland
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Christchurch, Canterbury
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Hamilton, Hamilton
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Hastings, Hastings

Other trials in New Zealand

Russia3 sites

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Moscow, Russia
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Saint Peterburg, Russia
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Smolensk, Smolensk Oblast

Other trials in Russia

Switzerland3 sites

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Bern, Canton of Bern
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Geneva
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Zurich, Canton of Zurich

Other trials in Switzerland

Austria2 sites

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Innsbruck, Innsbruck
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Vienna, State of Vienna

Other trials in Austria

Egypt2 sites

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Alexandria
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Cairo, Cairo Governorate

Other trials in Egypt

Mexico2 sites

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Mexico City, Mexico City
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Monterrey, Nuevo León

Other trials in Mexico

Romania2 sites

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Bucharest, Bucharest
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Bucharest, Sector 2

Other trials in Romania

Saudi Arabia2 sites

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Jeddah, Jeddah
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Riyadh, Riyadh Region

Other trials in Saudi Arabia

Slovakia2 sites

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Bratislava, Bratislava Region
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Košice, Košice Region

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Taiwan2 sites

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Neihu Taipei, R. O. C.
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Taipei

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Thailand2 sites

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Bangkok
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Khon Kaen

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Chile1 site

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Independencia, Santiago Metropolitan

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Lebanon1 site

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Beirut, Beirut

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Singapore1 site

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Singapore

Other trials in Singapore

About this study

Read the detailed description

Drotrecogin alfa (activated), a recombinant form of human activated protein C, is the first therapeutic intervention shown to reduce all-cause mortality in severe sepsis. In the Phase 3 study (F1K-MC-EVAD; PROWESS), 1690 patients were randomly assigned to receive a 96-hour intravenous infusion of drotrecogin alfa (activated) 24 micrograms/kg/h or placebo (850 patients and 840 patients, respectively). Overall, administration of drotrecogin alfa (activated) yielded a clinically significant reduction in 28-day all-cause mortality: 24.7% of drotrecogin alfa (activated) patients died versus 30.8% of placebo patients (19.4% relative risk reduction; p=0.005; Bernard et al. 2001). The only safety concern noted in the Phase 3 trial was an increased risk of serious bleeding among drotrecogin alfa (activated) patients (3.5% versus 2.0% of placebo patients). The difference between the two treatment groups in the number of patients who experienced a serious bleeding event was due to the greater number of drotrecogin alfa (activated) patients who experienced a serious bleeding event that was related to a procedure (for example, bleeding that resulted from the placement of a catheter or nephrostomy tube). The number of patients who experienced spontaneous serious bleeding events was similar between the two treatment groups.

The Regulatory authorities have approved the use of drotrecogin alfa (activated) in severe sepsis patients with a high level of disease severity and risk of death. Thus, the regulatory authorities have requested a study evaluating drotrecogin alfa (activated) in a specific subpopulation of patients with severe sepsis and at lower risk of death.

Conditions: Sepsis
Being tested: Drotrecogin alfa (activated)
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drotrecogin alfa (activated)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2002?

First posted10 Sep 2002 (estimated)
Study startSep 2002

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment

IDs, dates and publications

ClinicalTrials.gov ID: NCT00045760
Sponsor's protocol ID: 7252, 6669
Other IDs: F1K-MC-EVCL, F1K-MC-EVCM
Status last verified: Jul 2006
First submitted: 9 Sep 2002
Last updated: 20 Jul 2006
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients With Severe Sepsis
ClinicalTrials.gov ID: NCT00045760
Acronym / sponsor ID: 7252, 6669
Conditions: Sepsis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2002
First posted: 10 Sep 2002 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Adult patients with severe sepsis.
Presence of a suspected or proven infection.
One or more sepsis-associated organ failure.

Key exclusion criteria (4 listed)

Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country.
Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
Platelet count <30,000/mm3.
Are receiving therapeutic heparin.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drotrecogin alfa (activated)	Drug	–

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2006.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

426 sites in 32 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Drotrecogin alfa (activated) in people with Sepsis, run by Eli Lilly and Company at 426 sites in 32 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 426 sites in United States, France, Italy, Spain, United Kingdom and 27 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00045760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2006.