Follow-up Data of Patients Treated With XIGRIS® in France

Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France

The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France.

The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.

Study Overview

• Status: Completed
• Conditions: Sepsis

Detailed Description

The objectives of the study as defined by the specific requirements of Transparency Commission are as follows:

• To describe the characteristics of the patients treated with Xigris®

  • socio-demographic characteristics,
  • clinical profile

• To determine the conditions of use of Xigris®

  • To describe previous treatments,
  • To observe delay before Xigris® initiation,
  • To describe dose, duration of treatment,
  • To study the concomitant treatments and the associated treatments

• To describe the clinical evolution of the patients

  • To observe mortality after 1 month
  • To describe reasons of death

• Study Type: Observational
• Enrollment (Actual): 1004

Contacts and Locations

Study Locations

• France
  • Suresnes, France
    • For additional information regarding investigative sites for this study, 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients treated with Xigris® between January 1st, 2006 and August 31st 2008 in intensive care units in France will be enrolled retrospectively, whereas all adult patients treated with Xigris® between September 1st, 2008 and September 1st, 2009 will be enrolled prospectively.

Description

Patients are eligible to be included in the study if they meet the following criteria

• Patients treated with Xigris® during the study period in intensive care units in France
• Patients with a minimum age of 18 years
• Patients who are presenting in the normal course of care

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective cohort; Patient treated with Xigris between January 2006 and November 2008.
Prospective cohort; Patient treated with Xigris between November 2008 and November 2009.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	28 and 31 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Severe bleeding events	28 and 31 days
Length of hospital stay	28 and 31 days

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- fri 9AM-5PM eastern time (UTC/GMT- 5 hours,EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): February 2, 2010
• Last Update Submitted That Met QC Criteria: February 1, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: 12401; F1K-FR-B009 (Other Identifier: Eli Lilly and Company)