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

Primary Purpose

Febrile Neutropenia, Hematological Diseases

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Micafungin sodium
Itraconazole
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Febrile Neutropenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dong-A Medical Center
  • Severance Hospital
  • Korea University Guro Hospital
  • ASAN Medical Center
  • Ewha Womans University Mokdong Hospital
  • Samsung Medical Center
  • Ajou University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Micafungin sodium

Itraconazole

Outcomes

Primary Outcome Measures

Responses to therapy
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 definition of 'treatment failure': - If you failed any of 5 Items in 'treatment success'

Secondary Outcome Measures

Full Information

First Posted
April 25, 2011
Last Updated
December 4, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01344681
Brief Title
Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Neutropenia, Hematological Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Micafungin sodium
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Itraconazole
Intervention Type
Drug
Intervention Name(s)
Micafungin sodium
Other Intervention Name(s)
Mycamine®
Intervention Description
Treatment period (active treatment): an average 14 days Dosage: - Study Drug: Micafungin sodium (mycamine ® injections 50mg/vial) 2 vials (100mg / day) 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.
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Other Intervention Name(s)
Sporanox®
Intervention Description
Treatment period (active treatment): an average 14 days Dosage: - Active Comparator: Itraconazole (Sporanox ® injection) 200 mg 2 times(400mg / day) 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.
Primary Outcome Measure Information:
Title
Responses to therapy
Description
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 definition of 'treatment failure': - If you failed any of 5 Items in 'treatment success'
Time Frame
7 days after stopping study medication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dong-A Medical Center
City
Busan
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
ASAN Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Medical Center
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

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

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