drugset / Trial / NCT01344681

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

NCT01344681

Phase 2 Completed 153 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-06
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Itraconazole Small molecule 200 mg Intravenous
Subject Micafungin Peptide 100 mg

Indications