Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)
Status:
Completed
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
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). Duration of neutropenia is one of the most important risk factor for
invasive fungal infection (IFI). In this setting, Micafungin has been approved for antifungal
prophylaxis for patients undergoing Allo-SCT. In a randomized, double-blind, comparative,
phase III trial, the overall efficacy of micafungin was superior to that of fluconazole as
antifungal prophylaxis during the neutropenic phase after Allo-SCT. However, very few
patients in this study received a CB transplant.
This is phase IIb, prospective, open-label, non-comparative study to assess the safety of
micafungin when use in prevention of IFI in neutropenic patients receiving allo-SCT using CB
as source of stem cells.