Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion
A Phase IIIb Study to Determine Efficacy and Safety of Extended Drotrecogin Alfa (Activated) Therapy in Patients With Persistent Requirement for Vasopressor Support After 96 Hour Infusion With Commercial Drotrecogin Alfa (Activated)
2 other identifiers
interventional
200
2 countries
2
Brief Summary
The purpose of this study is to determine whether continued administration of Drotrecogin Alfa (Activated) up to additional 72 hours - after the so far recommended 96 hour infusion period - results in a more rapid resolution of hypotension in severe septic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 sepsis
Started Jun 2004
Typical duration for phase_3 sepsis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedOctober 12, 2007
October 1, 2007
September 12, 2005
October 10, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
- To assess whether continued administration of Drotrecogin Alfa (Activated)for up to 72 additional hours after 96 hours infusion of commercial DDA results in more rapid resolution of vasopressor-dependent hypotension
Secondary Outcomes (4)
Evaluate Reduction of 28-day all cause mortality
Evaluate effects on various organ functions over 14 days
Evaluate effects on the concentration of various biomarkers
Investigate safety profile of an extended infusion of DDA
Interventions
Eligibility Criteria
You may qualify if:
- Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)
- Continue requirement of Vasopressor support after 96 hour commercial infusion
You may not qualify if:
- Patients require extensive surgical procedures within next 3 days
- Patients with platelet count below 30,000/mm3
- Patients receiving therapeutic heparin of 15,000 units/day and more
- Patients not expected to survive 24 days
- Patients contraindicated as to the country specific registration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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.
Loma Linda, California, 92350, United States
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.
Paris, 75679, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
June 1, 2004
Study Completion
May 1, 2007
Last Updated
October 12, 2007
Record last verified: 2007-10