An open-label, non-controlled trial of prophylactic administration of voriconazole in patients who undergo allogeneic hematopoietic stem cell transplantation.

Not Applicable

• Conditions: Invasive fungal infection

• Registration Number: JPRN-UMIN000027218
• Lead Sponsor: ational Hospital Organization Nagoya Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-08
• Study Completion: 2020-05-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of proven/probable invasive aspergillosis until one year after transplantation.

Secondary Outcome Measures

Name	Time	Method
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.