Allogeneic Stem Cell Transplantation Clinical Trial
Official title:
Long-term Versus Short-term Sequential Therapy (Intravenous Itraconazole Followed by Oral Solution) of Itraconazole as Primary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation
- The primary objective of this study is to evaluate the efficacy and safety profile of
itraconazole as in primary prophylaxis
- The second objective of this study is to find the difference between long-term versus
short-term sequential therapy of Itraconazole (intravenous followed by oral
itraconazole) as primary prophylaxis of invasive fungal infections (IFI) in patients
undergoing allogeneic stem cell transplantation (allo-SCT)
- also to explore the relationship between the incidence of IFI with plasma
concentrations of itraconazole and hydroxy-itraconazole
Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients
receiving high dose chemotherapy or allo-SCT. Especially, patients undergoing allo-SCT
generally receive intensive immunosuppressive therapy, which make those patients at high
risk of developing IFI.
Prompt intensive antifungal therapy may increase the incidence rate of IFI and improved
responses and survival. Antifungal prophylaxis has been recommended in patients undergoing
allo-SCT by Infectious diseases society of America (IDSA) and Chinese guidelines for the
diagnosis and management of IFI in patients with hematologic/malignant tumor (revised).
Few studies have addressed the role of previous IFI in the feasibility of stem cell
transplant, or the secondary prophylaxis with antifungal drugs in preventing recurrence of
infection after transplantation. However, given the lack of prospective studies, the role of
primary antifungal prevention and the course of treatment remain unclear.
Itraconazole is a wide-spectrum triazole antifungal agent active against Candida albicans,
non-albicans, Aspergillus spp., Blastomyces dermatitidis, Blastomyces coccidioides,
Cryptococcus neoformans, Sporothrix schenkii, Paracoccidioides brasiliensis, Histoplasma
spp. and various kinds of yeast fungi and mycetes.
The role of itraconazole in IFI prophylaxis has been proved by many interventional studies.
However the optimal course of prophylaxis is still unknown,especially in China. In this
prospective, multicentric study of primary antifungal prevention, long-term or short-term
sequential therapy (intravenous followed by oral itraconazole) will be given at standard
dose to patients undergoing allogeneic stem cell transplantation to assess the efficacy and
safety of itraconazole in primary prophylaxis, and to analysis the relationship between the
incidence rate of IFI with plasma concentrations of itraconazole and hydroxy-itraconazole.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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