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

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

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.

Study Overview

• Status: Terminated
• Conditions: Candidiasis; Aspergillosis
• Intervention / Treatment: Drug: Micafungin

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Changchun, China
  • Chongqing, China
  • Fuzhou, China
  • Guangzhou, China
  • Hangzhou, China
  • Harbin, China
  • Hengyang, China
  • Jinan, China
  • Nanjing, China
  • Qingdao, China
  • Shijiazhuang, China
  • Taiyuan, China
  • Tianjing, China
  • Urumchi, China
  • Xi'an, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Micafungin group; Intravenous (IV)	Drug: Micafungin; Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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 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)
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)

Collaborators and Investigators

• Sponsor: Astellas Pharma China, Inc.

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results Web site

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2014
• Primary Completion (Actual): December 21, 2014
• Study Completion (Actual): December 21, 2014

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Micafungin; Candidiasis; Aspergillosis; Antifungal
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Candidiasis; Mycoses; Aspergillosis; Anti-Infective Agents; Antifungal Agents; Micafungin
• Other Study ID Numbers: ACN-MA-MYC-registry-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."