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

Candidiasis Clinical Trial

Official title:

A Multi-center, Open-label, Non-comparative Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02646800
• Other study ID #: ACN-MA-MYC-registry-2013
• Status: Terminated
• Phase: Phase 4
• Start date: March 21, 2014
• Est. completion date: December 21, 2014

Study information

• Verified date: January 2019
• 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 safety and efficacy of intravenous micafungin for the treatment of adult patients in China infected by Candida spp or Aspergillus spp.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 105
• Est. completion date: December 21, 2014
• Est. primary completion date: December 21, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aspergillosis
• Candidiasis
• Mycoses

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	Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis		Up to a maximum of 10 weeks
Primary	Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis		Up to a maximum of 14 weeks
Primary	Safety as assessed by adverse reactions for patients with candidiasis		Up to a maximum of 10 weeks
Primary	Safety as assessed by adverse reactions for patients with aspergillosis		Up to a maximum of 14 weeks
Secondary	Overall success rate for patients with candidiasis	Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)	End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Secondary	Overall success rate for patients with aspergillosis	Overall success rate=number of overall success patients/number of patients for efficacy evaluation × 100% at end of treatment (overall success is defined as patients with complete or partial response)	End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Secondary	Clinical Improvement rate for patients with candidiasis		End of treatment (up to up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis
Secondary	Clinical Improvement rate for patients with aspergillosis		End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Secondary	Fungal clearance rate for patients with candidiasis		End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Secondary	Fungal clearance rate for patients with aspergillosis		End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
Secondary	Fatality rate for patients with candidiasis		End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Secondary	Fatality rate for patients with aspergillosis		End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
Secondary	Safety as assessed by relationship of adverse events to Micafungin for patients with candidiasis		Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Secondary	Safety as assessed by relationship of adverse events to Micafungin for patients with aspergillosis		Day 1 to the end of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Secondary	Safety as assessed by liver and kidney function for patients with candidiasis		Day 1 to the end of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
Secondary	Safety as assessed by liver and kidney function for patients with aspergillosis		Day 1 to the end of treatment (up to 6 weeks, and up to 8 weeks, and up to 12 weeks for refractory patients)

External Links

•   Link to results on Astellas Clinical Study Results Web site