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NCT00190788 Clinical Trial

Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion

Sepsis Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00190788
Other study ID # 6001
Secondary ID F1K-MC-EVBQ
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated October 10, 2007
Start date June 2004
Est. completion date May 2007

Study information
Verified date October 2007
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Severe sepsis patients treated with 96 hour infusion of commercial Drotrecogin Alfa (Activated)

- Continue requirement of Vasopressor support after 96 hour commercial infusion

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Drotrecogin Alfa (Activated)

• placebo

Locations
Country Name City State
France 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
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. Loma Linda California

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  France, 

Outcome
Type Measure Description Time frame Safety issue
Primary - 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 Evaluate Reduction of 28-day all cause mortality
Secondary Evaluate effects on various organ functions over 14 days
Secondary Evaluate effects on the concentration of various biomarkers
Secondary Investigate safety profile of an extended infusion of DDA
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