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

Astellas

Status and phase: Completed; Phase 3

Conditions: Fungemia; Fungal Infections

Treatments: Drug: micafungin (Mycamine); Drug: itraconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00794703

MCFGCN02-0

Details and patient eligibility

About

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

Full 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

Enrollment: 288 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

1. Micafungin

Experimental group

Treatment:

Drug: micafungin (Mycamine)

2. Itraconazole

Active Comparator group

Treatment:

Drug: itraconazole