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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344681
First Posted: April 29, 2011
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose

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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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
Itraconazole
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®

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344681


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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01344681     History of Changes
Other Study ID Numbers: 4-2011-0794
First Submitted: April 25, 2011
First Posted: April 29, 2011
Last Update Posted: December 8, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Hematologic Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Body Temperature Changes
Signs and Symptoms
Itraconazole
Hydroxyitraconazole
Antifungal Agents
Miconazole
Micafungin
Echinocandins
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors