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

Astellas

Status and phase

Terminated

Phase 4

Conditions

Invasive Aspergillosis

Treatments

Drug: Micafungin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02646774

ACN-MA-MYC-IA-2012

Details and patient eligibility

About

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.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.