A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

Astellas Pharma Inc288 enrolled

Overview

The objective of this study is to compare the efficacy and safety between Mycamine and Itraconazole oral solution in preventing invasive fungal infections on autologous(malignant blood diseases) or allogeneic hematopoietic stem cell transplant patients

Dosing of Mycamine or Itraconazole will start at the beginning of the transplant conditioning regimen or within 48 hours after the transplant conditioning regimen, and administration time should be no longer than 42 days

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

288

Conditions

Fungemia Fungal Infections

Interventions

micafungin (Mycamine)DRUG

Intravenous

itraconazoleDRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients at risk of systemic fungal infections due to their immunocompromised state due to one of the following: * Patient with a hematologic malignancy undergoing an autologous hematopoietic stem cell transplant * Any patient undergoing an allogeneic hematopoietic stem cell transplant Exclusion Criteria: * Patients with moderate or severe liver disease, as defined by: * AST or ALT greater than 5 times upper limit of normal (ULN), OR; * Total bilirubin greater than 2.5 times ULN * Patients with evidence of a deeply invasive or disseminated fungal infection at time of enrollment

Locations (10)

Unnamed facility

Fuzhou, Fujian, China

Unnamed facility

Wuhan, Hubei, China

Unnamed facility

Chengdu, Sichuan, China

Unnamed facility

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Treatment success rate (fungal breakthrough rate)

Time frame: At the end of the study

Secondary Outcomes

Incidence of proven or probable invasive fungal infection

Time frame: Throughout the study period

The usage rate of systemic antifungal agents

Time frame: During 4 weeks after the administration

Time to treatment failure

Time frame: During the study period

Assessment of Adverse events, Laboratory examinations and vital signs evaluation

Time frame: Throughout the study period

Data from ClinicalTrials.gov

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