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

Lilly

Status: Completed

Conditions: Sepsis

Study type: Observational

Funder types: Industry

Identifiers

NCT00803231

F1K-FR-B009 (Other Identifier)

12401

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,004 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,004 participants in 2 patient groups

Retrospective cohort

Description:

Patient treated with Xigris between January 2006 and November 2008.

Prospective cohort

Description:

Patient treated with Xigris between November 2008 and November 2009.