Clinical trial NCT02646774: Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis
Official title: A Multi-center, Open-label, Non-comparative Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Aspergillosis (CFDA Commitment)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Invasive Aspergillosis
Keywords: Aspergillosis
Antifungal
Micafungin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall success rate for patients with no hematology disease
timeFrame: At the end of the treatment (up to a maximum of 4 weeks)
measure: Overall success rate for patients with hematology disease
timeFrame: At the end of the treatment (up to a maximum of 12 weeks)
Secondary outcomes:
measure: Clinical improvement rate for patients with no hematology disease
timeFrame: Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
measure: Clinical Improvement rate for patients with hematology disease
timeFrame: Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
measure: Fungal clearance rate for patients with no hematology disease
timeFrame: Week 1 up to the end of the treatment (up to a maximum of 4 weeks)
measure: Fungal clearance rate for patients with hematology disease
timeFrame: Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
measure: Fatality rate for patients with no hematology disease
timeFrame: End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients)
measure: Fatality rate for patients with hematology disease
timeFrame: End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
measure: Percentage of participants with common Aspergillus infection sites
timeFrame: End of treatment (up to 12 weeks)
measure: Safety assessed by adverse events
timeFrame: Up to 2 weeks after end of treatment (up to14 weeks)
Other outcomes:
Locations:
city: Beijing
country: China
city: Changsha
country: China
city: Chengdu
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Harbin
country: China
city: Hefei
country: China
city: Hengyang
country: China
city: Jinan
country: China
city: Nanchan
country: China
city: Shanghai
country: China
city: Shijiazhuang
country: China
city: Suzhou
country: China
city: Taiyuan
country: China
city: Tianjing
country: China
city: Wenzhou
country: China
city: Wuhan
country: China
city: Zhengzhou
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: