<?xml version="1.0" encoding="UTF-8"?>
<codeBook version="2.5" ID="FRESH-PEF73349-en" xml-lang="en" xmlns="ddi:codebook:2_5" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="ddi:codebook:2_5 https://ddialliance.org/Specification/DDI-Codebook/2.5/XMLSchema/codebook.xsd">
<docDscr>
  <citation>
    <titlStmt>
      <titl>Study on Antifungal Prophylaxis in High Risk Hematology patients</titl>
      <IDNo>FRESH-PEF73349-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="MSD FRANCE" role="">Laurie LEVY-BACHELOT</producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Study on Antifungal Prophylaxis in High Risk Hematology patients            </titl>
      <altTitl>
                    SAPHIR                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF73349-en            </IDNo>
      <IDNo agency="PEF">
                    73349                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF73349                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Thierry ALLAVOINE                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="MSD FRANCE">
        <ExtLink title="ROR" URI="https://ror.org/00kt5kp12" role="organisation id"/>
        <ExtLink title="SIREN" URI="417890589" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            MSD FRANCE                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            MSD FRANCE                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="" email="">
                    
                                    </contact>
      <depDate date="2026-06-16"/>
      <distDate date="2026-06-16"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <topcClas vocab="health theme">
                        Hematology                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/9239f328-78c9-40a5-a0b9-8e66fd9b6245"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D006402"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Neoplasms                                            </topcClas>
    </subject>
    <abstract contentType="purpose">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).</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date=""/>
      <collDate event="end" date=""/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Male                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008297"/>
                                                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe level="age" clusion="I">Middle Aged (45 to 64 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D008875"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged (65 to 79 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000368"/>
                                                    </universe>
      <universe level="age" clusion="I">Aged, 80 and over (80 years and more)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000369"/>
                                                    </universe>
      <universe 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 &lt; 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)                      </universe>
      <universe 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.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Participant-reported health data</dataKind>
    </sumDscr>
  </stdyInfo>
  <method>
    <dataColl>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>400</respRate>
    </anlyInfo>
    <stdyClas>Unknown</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access not yet planned</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
