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

Febrile Neutropenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344681
• Other study ID #: 4-2011-0794
• Status: Completed
• Phase: Phase 2
• First received: April 25, 2011
• Last updated: December 4, 2014
• Start date: June 2011
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Febrile Neutropenia
• Fever
• Hematologic Diseases
• Hematological Diseases
• Neutropenia

Intervention

Drug:
• Micafungin sodium
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.
• Itraconazole
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.

Locations

Country	Name	City	State
Korea, Republic of	Dong-A Medical Center	Busan
Korea, Republic of	ASAN Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou University Medical Center	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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'	7 days after stopping study medication	No