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
Phase 2
- Conditions
- Hematologic malignancy
- Registration Number
- JPRN-UMIN000006323
- Lead Sponsor
- Grants from the Japanese Ministry of Health, Labor and Welfare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
Not provided
Exclusion 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method