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

This study is currently recruiting participants.
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
  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
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'


Estimated Enrollment: 154
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344681

Locations
Korea, Republic of
Dong-A Medical Center Not yet recruiting
Busan, Korea, Republic of
Contact: Sung-Hyun Kim, MD, Ph.D    82-51-240-2608      
Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jin-Seok Kim, MD, Ph.D    82-2-2228-1972    hemakim@yuhs.ac   
Korea University Guro Hospital Not yet recruiting
Seoul, Korea, Republic of, 152-703
Contact: Cheol-Won Choi, MD, Ph.D    82-2-2626-1120      
Ewha Womans University Mokdong Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Yeong-Chul Mun, MD, Ph.D    82-2-2650-5114      
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jun-Ho Jang, MD, Ph.D    82-2-3410-3459      
ASAN Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Dae-Young Kim, MD, Ph.D    82-2-3010-3220      
Ajou University Medical Center Not yet recruiting
Suwon, Korea, Republic of
Contact: Joon-Seong Park, MD, Ph.D    82-31-219-5989      
Contact: Seong-Hyun Jeong, MD, Ph.D    82-31-219-5989      
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

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

Additional relevant MeSH terms:
Fever
Hematologic Diseases
Neutropenia
Body Temperature Changes
Signs and Symptoms
Agranulocytosis
Leukopenia
Leukocyte Disorders
Antifungal Agents
Itraconazole
Hydroxyitraconazole
Micafungin
Echinocandins
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014