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.

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Key information

Conditions

Febrile Neutropenia Agranulocytosis Cytopenia Hematologic Diseases Hematological Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Neutropenia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dong-A Medical Center, Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micafungin sodium

Drug

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.

Other names: Mycamine®

Itraconazole

Drug

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.

Other names: Sporanox®

Primary outcomes

Responses to therapy

Time frame: 7 days after stopping study medication
- 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'

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study 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

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Apr 29, 2011
Registry last updated: Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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