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Due to administrative reasons
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The objective of this study is to evaluate the safety and efficacy of intravenous micafungin for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micafungin group | Experimental | Intravenous (IV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis | Up to a maximum of 10 weeks | |
| Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis | Up to a maximum of 14 weeks | |
| Safety as assessed by adverse reactions for patients with candidiasis | Up to a maximum of 10 weeks | |
| Safety as assessed by adverse reactions for patients with aspergillosis | Up to a maximum of 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall success rate for patients with candidiasis | Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response) | End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Astellas Pharma Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| Overall success rate for patients with aspergillosis | Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response) | End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients) |
| Clinical Improvement rate for patients with candidiasis | End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis |
| Clinical Improvement rate for patients with aspergillosis | End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients) |
| Fungal clearance rate for patients with candidiasis | End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) |
| Fungal clearance rate for patients with aspergillosis | End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients |
| Fatality rate for patients with candidiasis | End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) |
| Fatality rate for patients with aspergillosis | End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients |
| Safety as assessed by relationship of adverse events to Micafungin for patients with candidiasis | Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) |
| Safety as assessed by relationship of adverse events to Micafungin for patients with aspergillosis | Day 1 to the end of treatment (up to 6 weeks, and up to 12 weeks for refractory patients) |
| Safety as assessed by liver and kidney function for patients with candidiasis | Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis) |
| Safety as assessed by liver and kidney function for patients with aspergillosis | Day 1 to the end of treatment (up to 6 weeks, and up to 8 weeks, and up to 12 weeks for refractory patients) |
| Changchun |
| China |
| Chongqing | China |
| Fuzhou | China |
| Guangzhou | China |
| Hangzhou | China |
| Harbin | China |
| Hengyang | China |
| Jinan | China |
| Nanjing | China |
| Qingdao | China |
| Shijiazhuang | China |
| Taiyuan | China |
| Tianjing | China |
| Ürümqi | China |
| Xi'an | China |
| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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