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

Phase 3

Completed

• Conditions: Fungemia; Fungal Infections
• Interventions: Drug: micafungin (Mycamine); Drug: itraconazole

• Registration Number: NCT00794703
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-19
• Study First Submitted QC: 2008-11-19
• Study First Posted: 2008-11-20
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-25
• Last Update Posted: 2016-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1. Micafungin	micafungin (Mycamine)	-
2. Itraconazole	itraconazole	-

Primary Outcome Measures

Name	Time	Method
Treatment success rate (fungal breakthrough rate)	At the end of the study

Secondary Outcome Measures

Name	Time	Method
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
Assessment of Adverse events, Laboratory examinations and vital signs evaluation	Throughout the study period
Time to treatment failure	During the study period