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Invasive fungal infections account for the majority of deaths due to infection in patients following allogeneic hematopoietic stem cell transplants, although toxicity secondary to antifungal agents and the emergence of resistant fungal strains are presenting clinical dilemmas.
This multicenter randomised open label trial compared prophylactic itraconazole (intravenous and oral) with fluconazole (intravenous and oral) in 140 patients over the age of 13 on the first day after transplantation and continued for 100 days with follow up until day 180 after transplantation or death. The primary end point was the incidence of invasive fungal infection and the secondary end points were the rates of superficial fungal infection, adverse events secondary to the study drug, mortality from fungal infection, and survival.
The incidence of invasive fungal infection was significantly lower in the patients given prophylactic itraconazole with lower though non-significant differences in mortality. Overall, the incidence of invasive fungal infection was high in this study compared with that of earlier studies. This was attributed both to the high use of corticosteroids (85%) which is associated with an increased risk of fungal infection and the generally increasing incidence reported throughout transplant centres in the United States.
The safe and effective use of itraconazole in patients undergoing allogeneic haematopoietic stem cell transplantation may represent an important advance in the prevention of possibly fatal invasive fungal infection, although gastrointestinal side effects were significantly higher in patients treated with itraconazole.