Liposomal amphotericin B(L-AMB) versus Micafungin(MCFG) for empirical therapy in patients of hematological disease with febrile neutropenia (FN) and persistent fever

Liposomal amphotericin B(L-AMB) versus Micafungin(MCFG) for empirical therapy in patients of hematological disease with febrile neutropenia (FN) and persistent fever - L-AMB versus MCFG in patients with FN

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006114

Enrollment

140

Registered

2011-08-04

Start date

2011-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Febrile neutropenia with persistent fever in patients with hematological disease

Interventions

Liposomal amphotericin B 2.5mg/kg div once a day Micafungin 150mg div once a day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged >= 16 years were eligible to participate if they had an absolute neutrophil count < 500/ uL for >=96 hours and fever (>=38 degrees C) within 24 hours before antifungal treatment in spite of antibacterial therapy for >=72 hours. 2) after obtaining signed informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
Safety assessed by 1) Discontinuation of therapy because of lack of efficacy or drug-related toxicity and 2) Incidence of drug-related adverse events	—

Countries

Japan

Contacts

Public ContactTatsuo Oyake

Iwate Medical University Hematology/Oncology

toyake@iwate-med.ac.jp+81-19-651-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026