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

Phase 2

Completed

• Conditions: Febrile Neutropenia; Hematological Diseases
• Interventions: Drug: Itraconazole; Drug: Micafungin sodium

• Registration Number: NCT01344681
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-27
• Study First Posted: 2011-04-29
• Study Start: 2011-06
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Itraconazole	Itraconazole
Arm A	Micafungin sodium	Micafungin sodium

Primary Outcome Measures

Name	Time	Method
Responses to therapy	7 days after stopping study medication	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'

Trial Locations

Locations (7)

Ajou University Medical Center; 🇰🇷 Suwon, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

ASAN Medical Center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Dong-A Medical Center; 🇰🇷 Busan, Korea, Republic of