Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases

PHASE2CompletedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Febrile NeutropeniaHematological Diseases
Interventions
DRUG

Micafungin sodium

"1. Treatment period (active treatment): an average 14 days~2. Dosage:~ \- Study Drug: Micafungin sodium (mycamine ® injections 50mg/vial) 2 vials (100mg / day)~3. Administration Method:~ * Study Drug: 3-5 days after fever begins. Infusion one time a day (one hour). Termination of treatment after maintaining fever for three days or the recovery of neutrophils with no fever."

DRUG

Itraconazole

"1. Treatment period (active treatment): an average 14 days~2. Dosage:~ \- Active Comparator: Itraconazole (Sporanox ® injection) 200 mg 2 times(400mg / day)~3. Administration Method:~ * Active Comparator: 200 mg two times(400 mg) a day, total of 4 times for 2 days and then one times (200 mg) a day for 12 days. Termination of treatment after keeping fever for three days or the recovery of neutrophils with no fever."

Trial Locations (7)

Unknown

Dong-A Medical Center, Busan

ASAN Medical Center, Seoul

Ewha Womans University Mokdong Hospital, Seoul

Samsung Medical Center, Seoul

Ajou University Medical Center, Suwon

120-752

Severance Hospital, Seoul

152-703

Korea University Guro Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER

NCT01344681 - Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases | Biotech Hunter | Biotech Hunter