Clinical trial NCT02646800: Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aspergillosis
Candidiasis
Keywords: Micafungin
Antifungal
Candidiasis
Aspergillosis
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety as assessed by overall incidence and severity of adverse events for patients with candidiasis
timeFrame: Up to a maximum of 10 weeks
measure: Safety as assessed by overall incidence and severity of adverse events for patients with aspergillosis
timeFrame: Up to a maximum of 14 weeks
measure: Safety as assessed by adverse reactions for patients with candidiasis
timeFrame: Up to a maximum of 10 weeks
measure: Safety as assessed by adverse reactions for patients with aspergillosis
timeFrame: Up to a maximum of 14 weeks
Secondary outcomes:
measure: Overall success rate for patients with candidiasis
timeFrame: 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)
measure: Overall success rate for patients with aspergillosis
timeFrame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
measure: Clinical Improvement rate for patients with candidiasis
timeFrame: 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
measure: Clinical Improvement rate for patients with aspergillosis
timeFrame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
measure: Fungal clearance rate for patients with candidiasis
timeFrame: End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
measure: Fungal clearance rate for patients with aspergillosis
timeFrame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
measure: Fatality rate for patients with candidiasis
timeFrame: End of treatment (up to 4 weeks, and up to 8 weeks for patients with chronic disseminated candidiasis, candida osteomyelitis, or candida endocarditis)
measure: Fatality rate for patients with aspergillosis
timeFrame: End of treatment (up to 6 weeks, and up to 12 weeks for refractory patients
measure: Safety as assessed by relationship of adverse events to Micafungin for patients with candidiasis
timeFrame: 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)
measure: Safety as assessed by relationship of adverse events to Micafungin for patients with aspergillosis
timeFrame: Day 1 to the end of treatment (up to 6 weeks, and up to 12 weeks for refractory patients)
measure: Safety as assessed by liver and kidney function for patients with candidiasis
timeFrame: 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)
measure: Safety as assessed by liver and kidney function for patients with aspergillosis
timeFrame: Day 1 to the end of treatment (up to 6 weeks, and up to 8 weeks, and up to 12 weeks for refractory patients)
Other outcomes:
Locations:
city: Beijing
country: China
city: Changchun
country: China
city: Chongqing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Harbin
country: China
city: Hengyang
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Qingdao
country: China
city: Shijiazhuang
country: China
city: Taiyuan
country: China
city: Tianjing
country: China
city: Urumchi
country: China
city: Xi'an
country: China
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References: