Candidemia, Candidiasis
Conditions
Keywords
Micafungin, candidiasis, candidemia, Open-label design
Brief summary
To evaluate the efficacy and safety of intravenous micafungin for the treatment of patients with proven or probable fungal infections caused by Candida sp. (Fungemia, respiratory mycosis, gastrointestinal mycosis) in adult patients in China.
Interventions
DRUGMicafungin
Intravenous (IV)
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 75 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test * The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results * The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia: 1. Risk factor (s) of infection 2. Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections 3. Two or more positive sputum culture for Candida
Exclusion criteria
* Patient received any other antifungal drug within 1 month prior to enrollment. * HIV positive patient * Patients with organ transplant * Patients with agranulocytosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall success rate | up to 8 weeks | success rate is calculated as (number of success patients/number of patients for efficacy evaluation × 100% at end of treatment) |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessed by the incidence of adverse events | up to 10 weeks |
Countries
China
Outcome results
None listed