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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Injection
Unnamed facility
Beijing, China
Unnamed facility
Changsha, China
Unnamed facility
Chengdu, China
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)
Time frame: 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)
Time frame: At the end of the treatment (up to a maximum of 12 weeks)
Clinical improvement rate for patients with no hematology disease
Time frame: Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Clinical Improvement rate for patients with hematology disease
Time frame: Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Fungal clearance rate for patients with no hematology disease
Time frame: Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
Fungal clearance rate for patients with hematology disease
Time frame: Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Fatality rate for patients with no hematology disease
Time frame: End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients)
Fatality rate for patients with hematology disease
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Unnamed facility
Fuzhou, China
Unnamed facility
Guangzhou, China
Unnamed facility
Hangzhou, China
Unnamed facility
Harbin, China
Unnamed facility
Hefei, China
Unnamed facility
Hengyang, China
Unnamed facility
Jinan, China
...and 9 more locations
Time frame: End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Percentage of participants with common Aspergillus infection sites
Time frame: End of treatment (up to 12 weeks)
Safety assessed by adverse events
Time frame: Up to 2 weeks after end of treatment (up to14 weeks)