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

Yonsei University153 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

153

Conditions

Febrile Neutropenia Hematological Diseases

Interventions

Micafungin sodiumDRUG

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.

ItraconazoleDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (7)

Dong-A Medical Center

Busan, South Korea

Severance Hospital

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

ASAN Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Responses to therapy

1. definition of 'treatment success': (5 Items to meet all your success) * Within 7 days after stopping study medication if there is no fungal infection * 7 days after stopping study medication if you are alive * Neutropenia period of serious adverse events or lack of effective medication is not stopped * If fever during neutropenia (temperature \<37.5 ℃) * Treatment until the end of the existing fungal infection is treated completely or partially 2. definition of 'treatment failure': - If you failed any of 5 Items in 'treatment success'

Time frame: 7 days after stopping study medication

Data from ClinicalTrials.gov

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