Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Aspergillosis (CFDA Commitment)

Conditions
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Invasive Aspergillosis

Intervention / Treatment
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* Drug: Micafungin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micafungin group<br>Injection | Drug: Micafungin<br>* Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aspergillosis, Antifungal, Micafungin