Follow-up Data of Patients Treated With XIGRIS® in France
- Conditions
- Sepsis
- Registration Number
- NCT00803231
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1004
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality 28 and 31 days
- Secondary Outcome Measures
Name Time Method Severe bleeding events 28 and 31 days Length of hospital stay 28 and 31 days
Trial Locations
- Locations (1)
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.
🇫🇷Suresnes, France