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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Micafungin sodium |
|
| Arm B | Active Comparator | Itraconazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin sodium | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Responses to therapy |
| 7 days after stopping study medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dong-A Medical Center | Busan | South Korea | ||||
| Severance Hospital |
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|
|
| Itraconazole | Drug |
|
|
|
| Seoul |
| 120-752 |
| South Korea |
| Korea University Guro Hospital | Seoul | 152-703 | South Korea |
| ASAN Medical Center | Seoul | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Ajou University Medical Center | Suwon | South Korea |
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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