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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Febrile Neutropenia, Hematological Diseases

Intervention / Treatment
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* Drug: Micafungin sodium
* Drug: Itraconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Micafungin sodium | Drug: Micafungin sodium<br>* Treatment period (active treatment): an average 14 days Dosage: - Study Drug: Micafungin sodium (mycamine ® injections 50mg/vial) 2 vials (100mg / day) Administration Method: Study Drug: 3-5 days after fever begins. Infusion one time a day (one hour). Termination of treatment after maintaining fever for three days or the recovery of neutrophils with no fever.<br>* Other names: Mycamine®;|
| Active Comparator: Arm B<br>Itraconazole | Drug: Itraconazole<br>* Treatment period (active treatment): an average 14 days Dosage: - Active Comparator: Itraconazole (Sporanox ® injection) 200 mg 2 times(400mg / day) Administration Method: Active Comparator: 200 mg two times(400 mg) a day, total of 4 times for 2 days and then one times (200 mg) a day for 12 days. Termination of treatment after keeping fever for three days or the recovery of neutrophils with no fever.<br>* Other names: Sporanox®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses to therapy | definition of 'treatment success': (5 Items to meet all your success) Within 7 days after stopping study medication if there is no fungal infection 7 days after stopping study medication if you are alive Neutropenia period of serious adverse events or lack of effective medication is not stopped If fever during neutropenia (temperature <37.5 ℃) Treatment until the end of the existing fungal infection is treated completely or partially definition of 'treatment failure': - If you failed any of 5 Items in 'treatment success' | 7 days after stopping study medication |