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Due to administrative reasons
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The objective of this study is to evaluate the efficacy and safety of intravenous micafungin for the treatment of proven or probable fungal infections caused by Aspergillus sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micafungin group | Experimental | Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micafungin | Drug | Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall success rate for patients with no hematology disease | Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response) | At the end of the treatment (up to a maximum of 4 weeks) |
| Overall success rate for patients with hematology disease | Overall success rate = number of success patients/number of patients for efficacy evaluation x 100% at end of treatment (overall success is defined as patients with complete or partial response) | At the end of the treatment (up to a maximum of 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical improvement rate for patients with no hematology disease | Week 1 up to the end of the treatment (up to a maximum of 4 weeks) | |
| Clinical Improvement rate for patients with hematology disease | Week 1 up to the end of the treatment (up to a maximum of 12 weeks) |
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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 website | 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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| Fungal clearance rate for patients with no hematology disease | Week 1 up to the end of the treatment (up to a maximum of 4 weeks) |
| Fungal clearance rate for patients with hematology disease | Week 1 up to the end of the treatment (up to a maximum of 12 weeks) |
| Fatality rate for patients with no hematology disease | End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients) |
| Fatality rate for patients with hematology disease | End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients) |
| Percentage of participants with common Aspergillus infection sites | End of treatment (up to 12 weeks) |
| Safety assessed by adverse events | Up to 2 weeks after end of treatment (up to14 weeks) |
| Changsha |
| China |
| Chengdu | China |
| Fuzhou | China |
| Guangzhou | China |
| Hangzhou | China |
| Harbin | China |
| Hefei | China |
| Hengyang | China |
| Jinan | China |
| Nanchan | China |
| Shanghai | China |
| Shijiazhuang | China |
| Suzhou | China |
| Taiyuan | China |
| Tianjing | China |
| Wenzhou | China |
| Wuhan | China |
| Zhengzhou | China |
| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| 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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