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

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 Overview

• Status: Completed
• Conditions: Febrile Neutropenia; Hematological Diseases
• Intervention / Treatment: Drug: Micafungin sodium; Drug: Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A Medical Center
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 152-703
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital
  • Suwon, Korea, Republic of
    • Ajou University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A; Micafungin sodium	Drug: Micafungin sodium; Treatment period (active treatment): an average 14 days; Dosage:- Study Drug: Micafungin sodium (mycamine ® injections 50mg/vial) 2 vials (100mg / day); 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.; Other Names: Mycamine®
ACTIVE_COMPARATOR: Arm B; Itraconazole	Drug: Itraconazole; Treatment period (active treatment): an average 14 days; Dosage:- Active Comparator: Itraconazole (Sporanox ® injection) 200 mg 2 times(400mg / day); 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.; Other Names: Sporanox®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responses to therapy	definition of 'treatment success': (5 Items to meet all your success)Within 7 days after stopping study medication if there is no fungal infection7 days after stopping study medication if you are aliveNeutropenia period of serious adverse events or lack of effective medication is not stoppedIf fever during neutropenia (temperature <37.5 ℃)Treatment until the end of the existing fungal infection is treated completely or partially; definition of 'treatment failure': - If you failed any of 5 Items in 'treatment success'	7 days after stopping study medication

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: April 25, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (ESTIMATE): April 29, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Agranulocytosis; Leukopenia; Leukocyte Disorders; Body Temperature Changes; Heat Stress Disorders; Neutropenia; Hematologic Diseases; Hyperthermia; Fever; Febrile Neutropenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Micafungin; Itraconazole
• Other Study ID Numbers: 4-2011-0794