Febrile neutropenia
Conditions
Interventions
Micafungin intravenously over 1 hour at a daily dose of 150 mg
Sponsors
Center for Supporting Hematology-Oncology Trials (C-SHOT)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Hematologic disease; (2) Age between 15 and 79; (3) Axillary temperature of 38.0 C or greater; (4) Absolute neutrophil count of less than 500/microL; (5) Persistent or recurrent fever after at least 96 hours of antibacterial therapy; (6) T-Bil level less than 2.0 times the upper limit of normal; (7) Cre level less than 1.5 times the upper limit of normal; (8) Written informed consent
Exclusion criteria
Exclusion criteria: (1) Past history of allergic reaction to the study drug; (2) MIcrobiological documented infection; (3) Having received systemic antifungal of antiviral therapy within 14 days; (4) Septic shock; (5) Allogeneic transplantation; (6) Body weight of less than 25 kg; (7) Positive for HIV antibody; (8) Pregnant or lactating woman
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | — |
Primary
| Measure | Time frame |
|---|---|
| Rate of treatment success as defined by a 4-component composite endpoint (defervescence, development of breakthrough fungal infections, discontinuation of the study drug, and death) | — |
Countries
Japan
Contacts
Public ContactEmi Goto
Nagoya University Graduate School of Medicine Department of Hematology and Oncology
Outcome results
None listed