A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia
- Registration Number
- NCT01982071
- Lead Sponsor
- Astellas Pharma China, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 59
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The diagnosis criteria of probable candida infection: Risk factors + Clinical Manifestations + positive findings including microbiologic test
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The diagnosis criteria of proven candida infection: Risk factors + Clinical Manifestation + positive findings including microbiologic test + tissue culture or pathological examination results
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The following 3 criteria must be met is a patient is diagnosed as probable candida pneumonia:
- Risk factor (s) of infection
- Clinical manifestations of infection and the pulmonary infection cannot be explained by other pathogenic infections
- Two or more positive sputum culture for Candida
- Patient received any other antifungal drug within 1 month prior to enrollment.
- HIV positive patient
- Patients with organ transplant
- Patients with agranulocytosis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group Micafungin Intravenous (IV)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety assessed by the incidence of adverse events up to 10 weeks