Voriconazole (VRCZ) versus Itraconazole (ITCZ) for fungal prophylaxis in allogeneic hematopoietic stem cell transplantation (HSCT) patients with graft-versus-host disease (GVHD): A multicenter randomized trial

UMIN ID: UMIN000006323

Registered date:12/09/2011

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hematologic malignancy
• Date of first enrollment: 2009/03/01
• Target sample size: 66
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

VRCZ arm (for 60 days) VRCZ tablet: 200 mg twice daily between meals for patients 40 kg or more, 100 mg twice daily between meals for patients less than 40 kg. If oral drug administration is not possible, intraveneous formulation (4 mg/kg, q12h) can be used.
ITCZ arm (for 60 days) ITCZ oral solution: 2.5 mg/kg twice daily before meals. If oral drug administration is not possible, intraveneous formulation (200 mg, q24h) can be used.

Outcome(s)

• Primary Outcome: The primary endpoint was the treatment success defined by the following criteria during the period from randomization to day 60: 1) alive 2) free from proven or probable invasive fungal infection defined by the revised EORTC criteria 3) able to continue the assigned drug for more than 80% of the study period (48 days or longer)

Key inclusion & exclusion criteria

• Age minimum: 16years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who had hypersensitivity against the study drugs. 2) Patients who received VRCZ or ITCZ within 7 days before registration. Patients who received antifungal drugs other than the study drugs (such as fluconazole and micafungin) can be registered if they discontinue the antifungal drugs before before registration. 3) Patients who had recurrent malignancies during the period from HSCT to registration. 4) Patients with chronic GVHD whose steroid dose was planed rapidly decreased within 3 weeks. 5) Patients who required medications that are contraindicated for the concurrent use of azoles.

Related Information

• Primary Sponsor: Grants from the Japanese Ministry of Health, Labor and Welfare
• Source(s) of Monetary Support: Grants from the Japanese Ministry of Health, Labor and Welfare