ITMO public health
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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