SepsisNCT00803231
Follow-up Data of Patients Treated With XIGRIS® in France
An observational study of Sepsis, run by Eli Lilly and Company at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 1,004 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
France1 site
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
About this study
Official title: Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) 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.
Read the 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
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective cohort | Patient treated with Xigris between January 2006 and November 2008. | |
| Prospective cohort | Patient treated with Xigris between November 2008 and November 2009. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 28 and 31 days
Secondary outcomes (2)
Severe bleeding events
Measured: 28 and 31 days
Length of hospital stay
Measured: 28 and 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- fri 9AM-5PM eastern time (UTC/GMT- 5 hours,EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803231
- Sponsor's protocol ID
- 12401
- Other IDs
- F1K-FR-B009
- Status last verified
- Feb 2010
- First submitted
- 4 Dec 2008
- Last updated
- 2 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France
- ClinicalTrials.gov ID
- NCT00803231
- Acronym / sponsor ID
- 12401
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective cohort | – | –Patient treated with Xigris between January 2006 and November 2008. |
| Prospective cohort | – | –Patient treated with Xigris between November 2008 and November 2009. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 28 and 31 days
2 secondary outcomes
Severe bleeding events
Time frame: 28 and 31 days
Length of hospital stay
Time frame: 28 and 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- fri 9AM-5PM eastern time (UTC/GMT- 5 hours,EST) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Eli Lilly and Company at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 28 and 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2010.