Status:
COMPLETED
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Severe Sepsis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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/...
Eligibility Criteria
Inclusion
- Must be 18 years or older
- Must have a suspected or proven infection
- Must have two or more sepsis-associated organ dysfunctions
Exclusion
- Documented multiple organ dysfunction greater than 24 hours prior to start of study drug
- Actual body weight less than 30 kg or more than 135 kg
- Platelet count less than 30,000/mm\^3
- Active internal bleeding or at increased risk of bleeding
- Not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT00386425
Start Date
November 1 2006
End Date
August 1 2009
Last Update
December 16 2010
Active Locations (47)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phoenix, Arizona, United States, 85013
2
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Scottsdale, Arizona, United States, 85258
3
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fresno, California, United States, 93701
4
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Loma Linda, California, United States, 92350