Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases

A Randomized Phase II, Multi-center, Non-inferiority Clinical Trial for Efficacy and Safety of Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases

This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials.

Therefore, this study was planned for review of the safety and efficacy in korean patients.

Inclusion Criteria:

• The male and female patients over 18 years
• To participate in clinical trials and voluntary written consent requirement to comply with a patient
• Chemotherapy with a variety of hematologic malignancies or patients undergoing stem cell transplantation
• Fever (temperature ≥ 38.4 ℃) showing Neutropenia (absolute neutrophil count <500/mm3) patients
• Combined antibiotic therapy 72 hours after the expiration of term lasts three patients

Exclusion Criteria:

• Of clinical trials of breast-feeding or pregnant women of childbearing age with intent to
• Adapted species (candida genus, aspergillus genus) Colitis caused by fungi other than the patients with fungal infection
• HIV-positive patient serum
• This test within 30 days of assignment to the other patients participating in clinical trials
• Within 72 hours of registration before the patients treated with systemic antifungal agents