QALIFF - Prospective observational study on the quality of life of patients with Clostridium difficile infection
Head :
Levy Bachelot Laurie
Last update : 10/19/2017 | Version : 1 | ID : 73339
| General | |
| Identification | |
| Detailed name | Prospective observational study on the quality of life of patients with Clostridium difficile infection |
| Sign or acronym | QALIFF |
| General Aspects | |
| Medical area |
Infectious diseases |
| Pathology (details) | Clostridium difficile infection |
| Health determinants |
Others (specify) |
| Others (details) | quality of life, sociodemographic and clinical characteristics of patients, therapeutic management |
| Keywords | Clostridium difficile infection, quality of life |
| Scientific investigator(s) (Contact) | |
| Name of the director | Levy Bachelot |
| Surname | Laurie |
| Address |
34 avenue Léonard de Vinci 92418 Courbevoie cedex |
| Organization | MSD |
| Collaborations | |
| Participation in projects, networks and consortia |
No |
| Funding | |
| Funding status |
Private |
| Details | MSD France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | MSD France |
| Organisation status |
Private |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Evaluate the consequences of a Clostridium difficile infection (CDI) on the quality of life of the patients through the progression of the EQ-5D profile before/during the episode |
| Inclusion criteria |
Inclusion criteria
- Adult patient with CDI, regardless of the reason for hospitalisation, - Patient having given informed consent. Exclusion criteria - Patient under 18 years of age. - Patient without telephone. - Patient unable to answer questionnaire (language barrier, cognitive deficits). - Patient refusing to participate. - Patient with chronic Inflammatory Bowel Disease (IBD). - Patient included in a therapeutic trial at the time of the study |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | XI - Diseases of the digestive system |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | place of hospitalisation |
| Data collection | |
| Dates | |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 250 theoretical patients |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Administrative data Utility / preference data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Face to face interview Phone interview |
| Presence of a biobank |
No |
| Procedures | |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | No data access charter |
| Access to aggregated data |
Access not yet planned |
| Access to individual data |
No access |
