iposomal amphotericin B(L-AMB) versus Micafungin(MCFG) for empirical therapy in patients of hematological disease with febrile neutropenia (FN) and persistent fever
Not Applicable
- Conditions
- Febrile neutropenia with persistent fever in patients with hematological disease
- Registration Number
- JPRN-UMIN000006114
- Lead Sponsor
- Iwate Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 140
Inclusion Criteria
Not provided
Exclusion Criteria
1) AST/ALT/total bilirubin > 5 times the upper limit of normal(at each institution). 2) Creatinine clearance <= 30ml/min or serum creatinine >=2mg/dl. 3) History of allergy or hypersensitivity to L-AMB or MCFG. 4) Pregnancy or lactation. 5) Patients who are regarded as inadequate subjects by physician in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy assessed by 1) Successful treatment of any baseline fungal infection, 2) Absence of any breakthrough fungal infection during therapy or within seven days after the completion of therapy, 3) Survival for seven days after the completion of therapy, 4) No premature discontinuation of study therapy because of lack of efficacy or drug-related toxicity and 5) Resolution of fever (defined as a temperature below 38 degrees C for at least 48 hours) during neutropenia
- Secondary Outcome Measures
Name Time Method Safety assessed by 1) Discontinuation of therapy because of lack of efficacy or drug-related toxicity and 2) Incidence of drug-related adverse events