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Trial record 6 of 1957 for:    Open Studies | "Hematologic Diseases"
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Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases

This study is currently recruiting participants.
Verified September 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01344681
First received: April 25, 2011
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

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: 152
Study Start Date: June 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (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: September 11, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hematologic Diseases
Fever
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 May 19, 2013