Invasive Aspergillosis
Conditions
Keywords
Aspergillosis, Antifungal, Micafungin
Brief summary
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.
Interventions
DRUGMicafungin
Injection
Sponsors
Astellas Pharma China, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are diagnosed as proven or probable infections caused by aspergillus (including fungemia, respiratory mycosis and gastrointestinal mycosis) with reference to the definition of EORTC/MSG * Females of childbearing potential are not pregnant in the study and reliable methods of contraception should be maintained during the whole study. * Patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained.
Exclusion criteria
* Patient received any echinocandins drug within 1 month prior to enrollment. * Patient was enrolled in any other clinical study within the last month. * AST/ALT \> 5 times the upper limit of normal (ULN) * total bilirubin\> 2.5 times ULN * BUN/Ccr \> 3 times ULN * HIV positive patient * Patient has a history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins. * Patient has a life expectancy of \<1 month * Subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance. * Pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception for the duration of the study and for 6 weeks following completion of the study. * Patient has been previously enrolled in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall success rate for patients with no hematology disease | At the end of the treatment (up to a maximum of 4 weeks) | 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) |
| Overall success rate for patients with hematology disease | At the end of the treatment (up to a maximum of 12 weeks) | 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
| 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) |
| Fatality rate for patients with hematology disease | End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients) |
| Clinical Improvement rate for patients with hematology disease | Week 1 up to the end of the treatment (up to a maximum of 12 weeks) |
Countries
China
Outcome results
None listed