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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 10, 2007

Start Date ^ICMJE

June 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

- 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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00190788 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

- 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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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)

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sepsis
Hypotension

Intervention ^ICMJE

Drug: Drotrecogin Alfa (Activated)
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

200

Completion Date

May 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, France

Administrative Information

NCT ID ^ICMJE

NCT00190788

Responsible Party

Study ID Numbers ^ICMJE

6001, F1K-MC-EVBQ

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Eli Lilly and Company

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP