NCT01344681

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

A Randomized Phase II, Multi-center, Non-inferiority Clinical Trial for Efficacy and Safety of Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Yonsei University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. The investigators evaluate efficacy and safety of micafungin sodium (mycamine ® Injection) 100mg dose compare to itraconazole (Sporanox ® Injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials. Therefore, this study was planned for review of the safety and efficacy in korean patients.

Conditions

• Febrile Neutropenia
• Hematological Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-06-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-04-29
• Last updated: 2014-12-08

Locations

7 sites across 1 country: South Korea