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

Invasive Aspergillosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02646774
• Other study ID #: ACN-MA-MYC-IA-2012
• Status: Terminated
• Phase: Phase 4
• Start date: March 1, 2014
• Est. completion date: June 26, 2015

Study information

• Verified date: December 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: June 26, 2015
• Est. primary completion date: June 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aspergillosis
• Invasive Aspergillosis

Intervention

Drug:
• Micafungin
Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	Clinical Improvement rate for patients with hematology disease		Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Secondary	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)
Secondary	Fungal clearance rate for patients with hematology disease		Week 1 up to the end of the treatment (up to a maximum of 12 weeks)
Secondary	Fatality rate for patients with no hematology disease		End of the treatment (up to 2 weeks, and up to 4 weeks for refractory patients)
Secondary	Fatality rate for patients with hematology disease		End of the treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Secondary	Percentage of participants with common Aspergillus infection sites		End of treatment (up to 12 weeks)
Secondary	Safety assessed by adverse events		Up to 2 weeks after end of treatment (up to14 weeks)

External Links

•   Link to results on Astellas Clinical Study Results website