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

Study Overview
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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

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

Official Title
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A Multi-center, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of Mycamine® vs Itraconazole Oral Solution for Prophylaxis of Fungal Infections in Patients Undergoing a Hematopoietic Stem Cell Transplant

Conditions
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Fungemia, Fungal Infections

Intervention / Treatment
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* Drug: micafungin (Mycamine)
* Drug: itraconazole


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Micafungin<br> | Drug: micafungin (Mycamine)<br>* Intravenous<br>* Other names: FK463;|
| Active Comparator: 2. Itraconazole<br> | Drug: itraconazole<br>* oral<br>* Other names: Sporanox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success rate (fungal breakthrough rate) |  | At the end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of proven or probable invasive fungal infection |  | Throughout the study period | 
| The usage rate of systemic antifungal agents |  | During 4 weeks after the administration | 
| Time to treatment failure |  | During the study period | 
| Assessment of Adverse events, Laboratory examinations and vital signs evaluation |  | Throughout the study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antifungal, micafungin, itraconazole