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

Primary Purpose

Sepsis, Hypotension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Drotrecogin Alfa (Activated)
placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 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.
  • 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.

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
October 10, 2007
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00190788
Brief Title
Extended Therapy of Drotrecogin Alfa (Activated) 4 vs 7 Days Infusion
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Hypotension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Drotrecogin Alfa (Activated)
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
- 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 Measure Information:
Title
Evaluate Reduction of 28-day all cause mortality
Title
Evaluate effects on various organ functions over 14 days
Title
Evaluate effects on the concentration of various biomarkers
Title
Investigate safety profile of an extended infusion of DDA

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Facility Name
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.
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

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

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