Invasive Fungal Infection Clinical Trial
Official title:
Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation
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.
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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