A double-blind, randomized, placebo-controlled trial of itraconazole capsules as antifungal prophylaxis for neutropenic patients

To evaluate the efficacy of itraconazole capsules in prophylaxis for fungal infections in neutropenic patients, we conducted a prospective, double-bli nd, placebo-controlled, randomized trial. Patients with hematologic maligna ncies or those who received autologous bone marrow transplants were assigne d either a regimen of itraconazole (100 mg orally twice daily; n = 104) or of placebo (n = 106). Overall, fungal infections (superficial or systemic) occurred more frequently in the placebo group (15% vs. 6%; P=.03), There we re no differences in the empirical use of amphotericin B or systemic fungal infections. Among patients with neutropenia that was profound (<100 neutro phils/mm(3)) and prolonged (for at least 7 days), those receiving itraconaz ole used less empirical amphotericin B (22% vs. 61%; P=.0001) and developed fewer systemic fungal infections (6% vs, 19%; P=.04). For patients with pr ofound and prolonged neutropenia, itraconazole capsules at the dosage of 10 0 mg every 12 h reduce the frequency of systemic fungal infections and the use of empirical amphotericin B.