A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients With Severe Sepsis and Multiple Organ Dysfunction
A Phase 2 Study to Evaluate Dose and Duration of Treatment of Drotrecogin Alfa (Activated) Using Serial Measurements of Protein C in Patients With Severe Sepsis and Multiple Organ Dysfunction
In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration [24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.
Note: The protocol was amended to remove the option of shorter infusion durations.
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85013, United States
Scottsdale, Arizona 85258, United States
Fresno, California 93701, United States
Loma Linda, California 92350, United States
Stanford, California 94305, United States
Washington D.C., District of Columbia 20037, United States
Orlando, Florida 32806, United States
Idaho Falls, Idaho 83404, United States
Indianapolis, Indiana 46202, United States
Louisville, Kentucky 40202, United States
Portland, Maine 04102, United States
Minneapolis, Minnesota 55455, United States
St Louis, Missouri 63141, United States
Greensboro, North Carolina 27401, United States
Abington, Pennsylvania 19001, United States
Rapid City, South Dakota 55701, United States
Houston, Texas 77030, United States
Brussels, 1070, Belgium
Ghent, 9000, Belgium
Vancouver, British Columbia V6Z 1Y6, Canada
Winnipeg, Manitoba R2H 2A6, Canada
Halifax, Nova Scotia B3H 1V7, Canada
London, Ontario N6C 2V5, Canada
Ottawa, Ontario K1H 8L6, Canada
Toronto, Ontario M4N 3M5, Canada
Fleurimont, Quebec J1H 5N4, Canada
Helsinki, 00290, Finland
Kuopio, 70211, Finland
Oulu, 90220, Finland
Tampere, 33521, Finland
Angoulême, 16470, France
La Roche-sur-Yon, 85925, France
Limoges, 87042, France
Poitiers, 86021, France
Tours, 37044, France
Hamburg, 21075, Germany
Jena, D-07740, Germany
Leipzig, D-04103, Germany
San Juan, 00921, Puerto Rico
Sabadell, 08208, Spain
Reading, Berkshire RG1 5AN, United Kingdom
Brighton, East Sussex BN2 5BE, United Kingdom
Cottingham, East Yorkshire HU16 5JQ, United Kingdom
London, Greater London W6 8RF, United Kingdom
Waterloo, London SE1 7EH, United Kingdom
Kings Lynn, Norfolk PE30 4ET, United Kingdom