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The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients
Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Micafungin | Experimental |
| |
| 2. Itraconazole | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micafungin (Mycamine) | Drug | Intravenous |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment success rate (fungal breakthrough rate) | At the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of proven or probable invasive fungal infection | Throughout the study period | |
| The usage rate of systemic antifungal agents | During 4 weeks after the administration | |
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Inclusion Criteria:
Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following:
Exclusion Criteria:
Patients with moderate or severe liver disease, as defined by:
Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou | Fujian | China | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22469884 | Derived | Huang X, Chen H, Han M, Zou P, Wu D, Lai Y, Huang H, Chen X, Liu T, Zhu H, Wang J, Hu J. Multicenter, randomized, open-label study comparing the efficacy and safety of micafungin versus itraconazole for prophylaxis of invasive fungal infections in patients undergoing hematopoietic stem cell transplant. Biol Blood Marrow Transplant. 2012 Oct;18(10):1509-16. doi: 10.1016/j.bbmt.2012.03.014. Epub 2012 Mar 30. |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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| ID | Term |
|---|---|
| D016469 | Fungemia |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D000072742 | Invasive Fungal Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| itraconazole | Drug | oral |
|
|
| Time to treatment failure |
| During the study period |
| Assessment of Adverse events, Laboratory examinations and vital signs evaluation | Throughout the study period |
| Wuhan |
| Hubei |
| China |
| Chengdu | Sichuan | China |
| Hangzhou | Zhejiang | China |
| Beijing | China |
| Jiangsu | China |
| Nanning | China |
| Shanghai | China |
| Tianjin | China |
| Xi'an | China |
| D018746 |
| Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |