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

NCT02646800 | Terminated Phase 4

• 1 other identifier: ACN-MA-MYC-registry-2013
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 16

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.

Conditions

Aspergillosis; Candidiasis

Keywords

Micafungin; Antifungal; Candidiasis; Aspergillosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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 for patients with aspergillosis

  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)

Study Arms (1)

Micafungin group

EXPERIMENTAL

Intravenous (IV)

Drug: Micafungin

Interventions

Micafungin DRUG

Injection

Micafungin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (16)

Unknown Facility

Beijing, China

Location

Unknown Facility

Changchun, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Fuzhou, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Harbin, China

Location

Unknown Facility

Hengyang, China

Location

Unknown Facility

Jinan, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Qingdao, China

Location

Unknown Facility

Shijiazhuang, China

Location

Unknown Facility

Taiyuan, China

Location

Unknown Facility

Tianjing, China

Location

Unknown Facility

Ürümqi, China

Location

Unknown Facility

Xi'an, China

Location

Related Links

• Link to results on Astellas Clinical Study Results Web site

MeSH Terms

Conditions

Aspergillosis; Candidiasis

Interventions

Micafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: January 6, 2016
• Study Start: March 21, 2014
• Primary Completion: December 21, 2014
• Study Completion: December 21, 2014
• Last Updated: November 7, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)