FRESH-PEF73349-en
Study on Antifungal Prophylaxis in High Risk Hematology patients
SAPHIR
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data']
Individuals
| Topic | Vocabulary |
|---|---|
| Hematology | health theme |
| Neoplasms | cim-11 |
{
"level_sex_clusion_I": [
{
"value": "Male",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
}
},
{
"value": "Female",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
}
}
],
"level_age_clusion_I": [
{
"value": "Young Adult (19 to 24 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
}
},
{
"value": "Adult (25 to 44 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
}
},
{
"value": "Middle Aged (45 to 64 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
}
},
{
"value": "Aged (65 to 79 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
}
},
{
"value": "Aged, 80 and over (80 years and more)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000369"
}
}
],
"level_type_clusion_I": [
"Patients population"
],
"level_type_clusion_other": "",
"clusion_I": "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) ",
"clusion_E": "Patients meeting the following criteria should not be included 1. Patient refusing to participate to the study.criteria will be reviewed by the investigator or qualified designee to ensure that the subject qualifies for the study."
}
| Name |
|---|
| Thierry;ALLAVOINE |
| Name | Role |
|---|---|
| MSD FRANCE | sponsor |
| Name |
|---|
| MSD FRANCE |
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access not yet planned
Observational Study
{"value":"To be defined","extLink":[]}
FRESH-PEF73349-en
| Name | Affiliation |
|---|---|
| Laurie LEVY-BACHELOT | MSD FRANCE |