Invasive fungal infection
Conditions
Interventions
Oral administration of voriconazole is started seven days before the transplantation day, at least for 100 days after the transplantation until neutrophils reach 500/micro L or more and immunosuppress
Sponsors
National Hospital Organization Nagoya Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients who are scheduled to undergo the first allogeneic hematopoietic stem cell transplantation at Nagoya Medical Center in the period from March 1, 2017 to February 28, 2019. 2)Patients who provided written consents for this study by themselves. 3)Patients aged 20 years or older at the time of acquisition of informed consent. 4)Patients who have not received voriconazole at the time of consent acquisition, or patients without proven/probable invasive fungal infection who are administered with voriconazole. 5)Patients with performance status (ECOG) of grade 0-3.
Exclusion criteria
Exclusion criteria: 1)Patients with proven/probable invasive fungal infection at the time of acquisition of informed consent (patients can be registered if cure is confirmed at the time of participation in the study and an antifungal drug is not used for therapeutic purpose). 2)Patients with a history of hypersensitivity to the components of voriconazole. 3)Patients with creatinine clearance less than 30 ml/min at the time of participation in the study. 4)Patients with grade C by Child-Pugh classification. 5)Patients with a complication of cardiac disease (including arrhythmia) which requires treatment. 6)Patients with a mental disorder, a psychiatric symptom, or cognitive impairment. 7)Patients who are pregnant, possibly pregnant, or breastfeed. 8)Patients who are taking or scheduled to be administered a prohibited drug concomitantly with voriconazole. 9)Patients under HIV treatment. 10)Patients for whom the principal investigator or other investigators decided not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of proven/probable invasive aspergillosis until one year after transplantation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Continuation rate of voriconazole administration at day+100 after transplantation. Adverse event due to voriconazole administration. Incidence rate of proven invasive fungal infection other than invasive aspergillosis during voriconazole administration. Relationship between blood concentration of voriconazole and incidence rate of proven/probable invasive fungal infection. Effect of voriconazole administration on blood concentration of a calcineurin inhibitor. | — |
Countries
Japan
Contacts
Public ContactHiroatsu Iida
National Hospital Organization Nagoya Medical Center Hematology
Outcome results
None listed