Invasive Fungal Infection Clinical Trial
Official title:
Efficacy of Itraconazole as Secondary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation or Chemotherapy With Prior Invasive Fungal Infection
Invasive fungal infections (IFI) remain the major cause of death among neutropenic patients
receiving chemotherapy for leukemia, or submitted to stem cell transplantation. Patients
with a history of invasive fungal infection (IFI) are at high risk of developing relapse and
fatal complications.
Prompt intensive antifungal therapy, have improved responses and survival, allowing an
increase of antifungal treatments, including secondary antifungal prophylaxis.
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
secondary antifungal prophylaxis remains 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 IFI prophylaxis treatment has been proved by many interventional
studies. In this prospective, multicentric study of secondary prophylaxis, itraconazole will
be given at standard dose to patients undergoing allogeneic stem cell transplantation or
chemotherapy with prior invasive fungal infection, to assess the efficacy and safety of
itraconazole secondary prophylaxis.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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