Last update : 01/01/2019 | Version : 1 | ID : 75
General | |
Identification | |
Detailed name | Follow-up study of patients treated with drotrecogin alfa (activated) (Xigris®) in France |
Sign or acronym | B009 |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°908282 |
General Aspects | |
Medical area |
Infectious diseases |
Others (details) | severe sepsis |
Keywords | Severe sepsis, drotrecogin alpha (activated), survival, conditions of use |
Scientific investigator(s) (Contact) | |
Name of the director | Laboratoire |
Fr_mail_pharmacoepi@lilly.com | |
Unit | Eli Lilly France |
Collaborations | |
Funding | |
Funding status |
Private |
Details | Eli Lilly and Company |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Eli Lilly |
Organisation status |
Private |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Longitudinal study (except cohorts) |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is is made on the basis of: |
Medication(s) taken |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | All intensive care services in French hospitals which treated patients with drotrecogin alpha (activated) during the study period were eligible. |
Database objective | |
Main objective |
Primary objective: evaluate 1-month mortality (at 28 days and 31 days) of patients treated with drotrecogin alpha (activated) in intensive care forsevere sepsis and describe causes of death. Secondary objectives: characteristics of patients and conditions of use. |
Inclusion criteria | All adult patients treated with drotrecogin alpha (activated) in France in the course of routine care in intensive care services. |
Population type | |
Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
Population covered |
Sick population |
Gender |
Male Woman |
Geography area |
National |
Detail of the geography area | National |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 2008 |
Date of last collection (YYYY or MM/YYYY) | 2009 |
Size of the database | |
Size of the database (number of individuals) |
[1000-10 000[ individuals |
Details of the number of individuals | 1049 |
Data | |
Database activity |
Data collection completed |
Type of data collected |
Clinical data Biological data |
Clinical data (detail) |
Direct physical measures Medical registration |
Biological data (detail) | hematology, biochemistry |
Presence of a biobank |
No |
Health parameters studied |
Health event/morbidity Health event/mortality |
Procedures | |
Data collection method | Study data collection form |
Participant monitoring |
Yes |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Reports and publications |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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