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OpenTrials
Completed

NCT Number: NCT00803231

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

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 28 and 31 days

Secondary outcomes

  1. Severe bleeding events

    Time frame: 28 and 31 days

  2. Length of hospital stay

    Time frame: 28 and 31 days

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2008
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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