Micafungin Versus Intravenous Itraconazole as Empirical Antifungal Therapy for Febrile Neutropenic Patients With Hematological Diseases
NCT ID: NCT01344681
Last Updated: 2014-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2011-06-30
2014-03-31
Brief Summary
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Therefore, this study was planned for review of the safety and efficacy in korean patients.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Micafungin sodium
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.
Arm B
Itraconazole
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Dong-A Medical Center
Busan, , South Korea
Severance Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
ASAN Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Ajou University Medical Center
Suwon, , South Korea
Countries
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Other Identifiers
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4-2011-0794
Identifier Type: -
Identifier Source: org_study_id