Background: Fungal infections still represent a major clinical problem in neutropenic patients; the recent availability of active imidazole derivatives, particularly fluconazole and itraconazole, has increased interest in prophylaxis.
Materials and methods: Fifty-nine consecutive bone marrow transplant (BMT) recipients were randomized to receive either itraconazole 400 mg/day or fluconazole 300 mg/day as oral antimycotic prophylaxis during the pancytopenic phase; they were retrospectively compared with a historical control group of 30 patients who had received fluconazole 50 mg/day. Every febrile episode was treated with the same empirical antibiotic combination; amphotericin-B was added after 4-5 days in the case of persistent fever. Proven or suspected mycotic infections and the empirical use of amphotericin-B were considered as failures of prophylaxis.
Results: There were no differences in the number of febrile episodes in the three groups. Five patient died of bacterial sepsis: two in the fluconazole 300, two in the itraconazole and one in the fluconazole 50 group. The addition of amphotericin-B was required in 12, 16 and 11 cases, respectively, in the three groups. There were four documented fungal infections in the intraconazole and one in both fluconazole groups; three suspected fungal infections were observed in the fluconazole 300 group and two in both the itraconazole and the fluconazole 50 group. None of the differences were statistically significant.
Conclusions: The present results indicate that high-dose fluconazole and itraconazole are equivalent; neither of them was superior to low-dose fluconazole, which is regarded as being devoid of prophylactic activity against systemic mycoses.