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

Phase 4TerminatedNCT02646800

Astellas Pharma China, Inc.105 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

105

Conditions

Aspergillosis Candidiasis

Interventions

MicafunginDRUG

Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (16)

Unnamed facility

Beijing, China

Unnamed facility

Changchun, China

Unnamed facility

Chongqing, China

Unnamed facility

Fuzhou, China

Outcomes

Primary Outcomes

Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis

Time frame: Up to a maximum of 10 weeks

Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis

Time frame: Up to a maximum of 14 weeks

Safety as assessed by adverse reactions for patients with candidiasis

Time frame: Up to a maximum of 10 weeks

Safety as assessed by adverse reactions for patients with aspergillosis

Time frame: Up to a maximum of 14 weeks

Secondary Outcomes

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)

Time frame: 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

Time frame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)

Clinical Improvement rate for patients with candidiasis

Time frame: 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

Data from ClinicalTrials.gov

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