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

Phase 4

Terminated

• Conditions: Candidiasis; Aspergillosis
• Interventions: Drug: Micafungin

• Registration Number: NCT02646800
• Lead Sponsor: Astellas Pharma China, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-21
• Primary Completion: 2014-12-21
• Study Completion: 2014-12-21
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Micafungin group	Micafungin	Intravenous (IV)

Primary Outcome Measures

Name	Time	Method
Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis	Up to a maximum of 10 weeks
Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis	Up to a maximum of 14 weeks
Safety as assessed by adverse reactions for patients with candidiasis	Up to a maximum of 10 weeks
Safety as assessed by adverse reactions for patients with aspergillosis	Up to a maximum of 14 weeks

Secondary Outcome Measures

Name	Time	Method
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)
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)
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)
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
Clinical Improvement rate for patients with aspergillosis	End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
Overall success 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)	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)
Fungal clearance rate for patients with aspergillosis	End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
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)
Overall success rate for patients with aspergillosis	End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)	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)
Fatality rate for patients with aspergillosis	End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
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)
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)