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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1004 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Groups

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Retrospective cohort

Patient treated with Xigris between January 2006 and November 2008.

No interventions assigned to this group

Prospective cohort

Patient treated with Xigris between November 2008 and November 2009.

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No