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

Yonsei University

Status and phase

Completed

Phase 2

Conditions

Febrile Neutropenia

Hematological Diseases

Treatments

Drug: Micafungin sodium

Drug: Itraconazole

Study type

Interventional

Funder types

Other

Identifiers

NCT01344681

4-2011-0794

Details and patient eligibility

About

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.

Enrollment

153 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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