Trial Information

Efficacy According to Treatment Timing in Immunocompromised Patients Treated With Itraconazole Injection as an Empiric Antifungal Therapy

This study is a multi-center, open-label, prospective and observational study enrolling
approximately 440 patients. The primary objective of this study is to examine the fever
response rate after itraconazole IV (directly into the vein) is administered for more than 3
days to patients with neutropenic fever based on investigator's discretion. Follow-up will
be performed before and after administration and for 7 days after administration. Study
population consists of the patients who visit a study center during the study period and are
judged to have neutropenic fever associated with hematologic malignancy such as acute
leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple
myeloma. The decision to treat patients with itraconazole is as per physician discretion and
doses are determined based upon approved labeling recommendations and physician discretion.
The safety and efficacy of itraconazole administered beyond 29 days is not yet been
established in the treatment of fever in neutropenic patients suspected of systemic fungal
infection. Itraconazole 200 mg IV twice daily for 2 days, for a total of 4 doses, then 200
mg IV once daily for 12 days. After the administration for a total of 14 days, itraconazole
oral solution 200 mg (20 ml) twice daily should be continued for a total of 14 days