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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-11-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Fungemia Fungal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1. Micafungin

Group Type EXPERIMENTAL

micafungin (Mycamine)

Intervention Type DRUG

Intravenous

2. Itraconazole

Group Type ACTIVE_COMPARATOR

itraconazole

Intervention Type DRUG

oral

Interventions

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micafungin (Mycamine)

Intravenous

Intervention Type DRUG

itraconazole

oral

Intervention Type DRUG

Other Intervention Names

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Mycamine FK463 Sporanox

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No