Fungal Infections, Fungemia
Conditions
Keywords
Antifungal, micafungin, itraconazole
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
Interventions
Intravenous
DRUGitraconazole
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success rate (fungal breakthrough rate) | At the end of the study |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed