Antifungal prophylaxis with Micafungin after cord blood allogeneic stem cell transplantation. - MycaCOORD

CHU de Nantes0 个研究点开始时间: 2015年9月28日最近更新: 2015年9月28日

试验速览

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•Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells (cf conditioning regimen recommendation).
•Sex male or female
•Age between 18 and 65 years at the time of signing the informed consent form.
•Diagnosis of an hematologic disease for who a allograft decision has been taken
•? not having a (HLA)-matched related or unrelated donor within two month after complete remission achievement
•Able to understand and voluntarily sign an informed consent form.
•Subjects affiliated with an appropriate social security system
•Male, female without childbearing potential or negative urine pregnancy test at the screening visit prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures. Men must agree to use an acceptable method of contraception (for themselves or female partners) for the duration of the study
•Each subject will weigh 40 kg or more
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 24
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Exclusion criteria
•Any suspected or documented invasive fungal infection at study entry or at any time prior to study entry
•Use of any systemic antifungal therapy within 72 hours prior to study entry
•Known history of allergy, hypersensitivity or intolerance to echinocandin agents
•Patient with any medical, psychological or social condition, which in the opinion of the investigator could increase the risk to the patient, or decrease the chance of obtaining satisfactory data to achieve the objectives of this study.
•Previous participation in this study.
•HIV, HBV or HCV positive
•Pregnant or breast feeding females.
•Subject protected by law.

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