Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

Astellas

Status and phase: Terminated; Phase 4

Conditions: Candidiasis; Aspergillosis

Treatments: Drug: Micafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02646800

ACN-MA-MYC-registry-2013

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of intravenous micafungin for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are diagnosed as proven/probable/possible fungal infection caused by Candida or Aspergillus based on the Chinese guidelines
• Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to the study and reliable methods of contraception should be started 4 weeks prior to and 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.
• Failure to fulfill inclusion criteria in another study, is not necessarily an exclusion criteria for this study, assuming other inclusion criteria 1-4 stated above are fulfilled.

Exclusion criteria

• Patient has history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins.
• 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.
• AST/ALT > 5 times the upper limit of normal (ULN)
• Total bilirubin> 2.5 times ULN
• Patient has been previously enrolled in this study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

Micafungin group

Experimental group

Description:

Intravenous (IV)

Treatment:

Drug: Micafungin