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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Antifungal Agents; Echinocandins; Hydroxyitraconazole; Itraconazole; Micafungin; Miconazole

Criteria

Inclusion Criteria:

• The male and female patients over 18 years

• To participate in clinical trials and voluntary written consent requirement to comply with a patient

• Chemotherapy with a variety of hematologic malignancies or patients undergoing stem cell transplantation

• Fever (temperature ≥ 38.4 ℃) showing Neutropenia (absolute neutrophil count <500/mm3) patients

• Combined antibiotic therapy 72 hours after the expiration of term lasts three patients

Exclusion Criteria:

• Of clinical trials of breast-feeding or pregnant women of childbearing age with intent to

• Adapted species (candida genus, aspergillus genus) Colitis caused by fungi other than the patients with fungal infection

• HIV-positive patient serum

• This test within 30 days of assignment to the other patients participating in clinical trials

• Within 72 hours of registration before the patients treated with systemic antifungal agents