Myelodysplastic Syndrome Clinical Trial
Official title:
A Randomized Open-Label Trial of Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
The purpose of this study is to compare the effects, good and/or bad, of posaconazole and
micafungin in preventing fungal infections after chemotherapy for acute leukemia or
myelodysplastic syndrome. When people take chemotherapy, they are more likely to get
infections. Posaconazole has been approved for the prevention of fungal infections in
patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome.
Posaconazole is available only as an oral suspension and has to be given with food. After
chemotherapy, many patients are not able to tolerate food or oral medication because of
severe mucositis. Patients unable to tolerate food and oral medications cannot take
posaconazole.
Micafungin is an antifungal medication that is given only intravenously. Micafungin is
approved for the treatment of certain fungal infections and for preventing fungal infections
in patients who receive bone marrow transplant. The investigators know that micafungin is
safe. Micafungin has not been tested for the prevention of fungal infections in patients
receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is
given by vein, it can be given even in patients who cannot take food or medications by mouth
after chemotherapy. In this study the investigators want to compare micafungin to
posaconazole when given for the prevention of fungal infections in leukemia and
myelodysplastic syndrome patients.
n/a
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