SAPHIR - Study on Antifungal Prophylaxis in High Risk Hematology patients
Head :
ALLAVOINE Thierry
Last update : 07/23/2018 | Version : 1 | ID : 73349
| General | |
| Identification | |
| Detailed name | Study on Antifungal Prophylaxis in High Risk Hematology patients |
| Sign or acronym | SAPHIR |
| General Aspects | |
| Medical area |
Hematology |
| Scientific investigator(s) (Contact) | |
| Name of the director | ALLAVOINE |
| Surname | Thierry |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | MSD France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | MSD France |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Database objective | |
| Main objective | The primary objective is to describe, in French hematological services, the monitoring and the therapeutic management of patients at high risk of IFDs under AF prophylaxis in real life clinical practices (imaging and laboratory exams for IFD diagnoses and surveillance, AF therapy prescribed, Therapeutic Drug Monitoring performed, facility environment). |
| Inclusion criteria |
Inclusion criteria :
In each center, all patients meeting the following criteria will be solicited to participate to the study. 1. Male or female adult patient, aged of 18 years old or more 2. Subject undergoing myelosuppressive intensive chemotherapy for AML with present or expected profound and prolonged neutropenia* 3. Initiating a systemic** antifungal prophylaxis (J0 = 1St day of administration of the AF) 4. Accepting to participate to the study * : Profound and prolonged neutropenia is define by an absolute value of neutrophils < 500/mm3 during 10 days ** : A systemic antifungal prophylaxis is defined by a treatment provided per os or in i.v. An oral suspension can be considered as a systemic use in function of the dose used (example: fluconazole ≥ 800mg/j is considered as a systemic treatment) Exclusion criteria : Patients meeting the following criteria should not be included 1. Patient refusing to participate to the study. All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee to ensure that the subject qualifies for 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 | II - Neoplasms |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | No details |
| Data collection | |
| Dates | |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 400 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Presence of a biobank |
No |
| Procedures | |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | InVS |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | No charte specific to data access |
| Access to aggregated data |
Access not yet planned |
| Access to individual data |
No access |
