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

This study has been completed.
Information provided by (Responsible Party):
Yonsei University Identifier:
First received: April 25, 2011
Last updated: December 4, 2014
Last verified: December 2014

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.

Condition Intervention Phase
Febrile Neutropenia
Hematological Diseases
Drug: Micafungin sodium
Drug: Itraconazole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Responses to therapy [ Time Frame: 7 days after stopping study medication ] [ Designated as safety issue: No ]
    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'

Enrollment: 153
Study Start Date: June 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
Micafungin sodium
Drug: Micafungin sodium
  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.
Other Name: Mycamine®
Active Comparator: Arm B
Drug: Itraconazole
  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.
Other Name: Sporanox®


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01344681

Korea, Republic of
Dong-A Medical Center
Busan, Korea, Republic of
ASAN Medical Center
Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 152-703
Samsung Medical Center
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752
Ajou University Medical Center
Suwon, Korea, Republic of
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University Identifier: NCT01344681     History of Changes
Other Study ID Numbers: 4-2011-0794
Study First Received: April 25, 2011
Last Updated: December 4, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Febrile Neutropenia
Hematologic Diseases
Leukocyte Disorders
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015