Aspergillosis, Candidiasis
Conditions
Keywords
Micafungin, Antifungal, Candidiasis, Aspergillosis
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.
Interventions
DRUGMicafungin
Injection
Sponsors
Astellas Pharma China, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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) |
| 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) | — |
| 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) | — |
| 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) |
| 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) | — |
Countries
China
Outcome results
None listed