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

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00190788

Purpose

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.

Condition	Intervention	Phase
Sepsis Hypotension	Drug: Drotrecogin Alfa (Activated) Drug: placebo	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Low Blood Pressure Sepsis

Drug Information available for: Drotrecogin alfa

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

- 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 Outcome Measures:

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

Estimated Enrollment:	200
Study Start Date:	June 2004
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190788

Locations

United States, California
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
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, France, 75679

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00190788 History of Changes
Other Study ID Numbers:	6001, F1K-MC-EVBQ
Study First Received:	September 12, 2005
Last Updated:	October 10, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypotension
Sepsis
Vascular Diseases
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Drotrecogin alfa activated
Protein C

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012