Evaluation of Antifungal Prophylaxis on Graft-versus-host Disease (GVHD) Patients
Status:
Terminated
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
Antifungal prophylaxis should be used in patients being treated with glucocorticoids for
graft-versus-host disease (GVHD) following allogeneic hematopoietic stem-cell transplantation
(HSCT). Although fluconazole has been widely used as an antifungal prophylactic agent after
allogeneic HSCT, fluconazole prophlaxis only shows a limited protective role against IFIs, is
not effective against invasive aspergillosis. In addition, NCCN guideline of the prevention
and treatment of cancer-related infections recommends antifungal prophylaxis in patients with
significant GVHD until resolution of GVHD using Posaconazole, Voriconazole, Echinocandin, or
Amphotericin B. However, under the National Health Insurance System, none of the drug can be
given prophylactically except itraconazole oral solution against IFIs. Itraconazole oral
solution shows excellent bioavailability and good efficacy against aspergillus and
fluconazole resistant candida infection.Based on these findings, we will perform prospective
multicenter study evaluating the efficacy, safety and long-term outcomes of itraconazole oral
solution prophylaxis against IFIs in patients treated with systemic corticosteroids for GVHD
after allogeneic HSCT.