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

• Status: Terminated
• Trial end date: 2015-06-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma China, Inc.
• Treatments: Echinocandins; Micafungin

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.