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

• Conditions: Adult patients receiving allo-Stem Cell Transplantation using Cord Blood as source of stem cells; MedDRA version: 18.0Level: PTClassification code 10010980Term: Cord blood transplant therapySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: PTClassification code 10049085Term: Antifungal prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-000103-16-FR
• Lead Sponsor: CHU de Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-28
• Last Update Posted: 28 September 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified