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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01344681
First received: April 25, 2011
Last updated: March 4, 2014
Last verified: March 2014

April 25, 2011
March 4, 2014
June 2011
December 2014   (final data collection date for primary outcome measure)
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'
Same as current
Complete list of historical versions of study NCT01344681 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Febrile Neutropenia
  • Hematological Diseases
  • 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®
  • 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®
  • Experimental: Arm A
    Micafungin sodium
    Intervention: Drug: Micafungin sodium
  • Active Comparator: Arm B
    Itraconazole
    Intervention: Drug: Itraconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Korea, Republic of
 
NCT01344681
4-2011-0794
No
Yonsei University
Yonsei University
Not Provided
Not Provided
Yonsei University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP