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

NCT00803231 | Completed

• 2 other identifiers: 12401F1K-FR-B009
• Study Type: observational
• Target: 1,004
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Mortality

  28 and 31 days

Secondary Outcomes (2)

• Severe bleeding events

  28 and 31 days

• Length of hospital stay

  28 and 31 days

Study Arms (2)

Retrospective cohort

Patient treated with Xigris between January 2006 and November 2008.

Prospective cohort

Patient treated with Xigris between November 2008 and November 2009.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 4, 2008
• First Posted: December 5, 2008
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 2, 2010

Record last verified: 2010-02

Locations

FR (1)