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Study on Antifungal Prophylaxis in High Risk Hematology patients

France
Reference ID
FRESH-PEF73349-en
Producer(s)
Thierry;ALLAVOINE
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Mar 13, 2026
Last modified
Mar 13, 2026
Page views
6
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Sampling
  • Survey instrument
  • Data collection
  • Data Access
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF73349-en

    Title

    Study on Antifungal Prophylaxis in High Risk Hematology patients

    Abbreviation or Acronym

    SAPHIR

    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data','Participant-reported health data']

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Hematology health theme
    Neoplasms cim-11

    Coverage

    Universe

    {
    "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."
    }

    Producers and sponsors

    Primary investigators
    Name
    Thierry;ALLAVOINE
    Producers
    Name Role
    MSD FRANCE sponsor
    Funding Agency/Sponsor
    Name
    MSD FRANCE

    Sampling

    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access not yet planned

    Methodology notes

    Observational Study

    Data collection

    Mode of data collection
    • {"concept":{"vocabURI":"Transcription","vocab":"CESSDA"},"value":"Converting or copying information into a structured record"}
    • {"concept":{"vocabURI":"Interview","vocab":"CESSDA"},"value":"Interview with the participant (including clinical)"}

    Data Access

    Availability Status

    {"value":"To be defined","extLink":[]}

    Metadata production

    DDI Document ID

    FRESH-PEF73349-en

    Producers
    Name Affiliation
    Laurie LEVY-BACHELOT MSD FRANCE
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