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

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00803231

Purpose

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.

Condition
Sepsis

MedlinePlus related topics: Sepsis

Drug Information available for: Drotrecogin alfa

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Mortality [ Time Frame: 28 and 31 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Severe bleeding events [ Time Frame: 28 and 31 days ] [ Designated as safety issue: Yes ]
Length of hospital stay [ Time Frame: 28 and 31 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	800
Study Start Date:	November 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
Retrospective cohort Patient treated with Xigris between January 2006 and November 2008.
Prospective cohort Patient treated with Xigris between November 2008 and November 2009.

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

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803231

Contacts

Contact: There may be multiple sites in this observational study 1-877-CTLILLY (1-877-285-4559)

1-317-615-4559

Locations

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.	Recruiting
Suresnes, France
Contact: Eli Lilly

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-5PM eastern time (UTC/GMT- 5 hours,EST)

Eli Lilly and Company

More Information

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	12401, F1K-FR-B009
Study First Received:	December 4, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00803231
Health Authority:	France: French Data Protection Authority; France: Haute Autorité de Santé Transparency Commission

Study placed in the following topic categories:

Drotrecogin alfa activated
Sepsis

ClinicalTrials.gov processed this record on January 16, 2009