Status:
COMPLETED
Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)
Lead Sponsor:
Nantes University Hospital
Conditions:
Invasive Fungal Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Infections due to post transplant immune deficiency are a major problem following allogeneic stem cell transplantation (Allo-SCT), particularly in patients receiving cord blood transplant (CB). Durati...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Participation in a study testing a new drug or a new conditioning
- HIV, HBV or HCV positive
- Pregnant or breast feeding females.
- Subject protected by law.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01888458
Start Date
September 1 2013
End Date
April 1 2016
Last Update
May 20 2016
Active Locations (1)
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1
CHU de Nantes
Nantes, France, 44093