EFFICACY OF ITRACONAZOLE IN THE PREVENTION OF FUNGAL-INFECTIONS AMONGNEUTROPENIC PATIENTS WITH HEMATOLOGIC MALIGNANCIES AND INTENSIVE CHEMOTHERAPY - A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY

We studied the efficacy and safety of itraconazole for the prevention of fungal infection in neutropenic patients given cytotoxic chemothera py for hematologic malignancies. Patients were randomly allocated to r eceive either itraconazole (200 mg bd) or placebo in addition to oral amphotericin B until the patient either developed fungal infection or had completed antileukemic treatment. Forty six patients (83 neutropen ic episodes) treated with itraconazole and 46 placebo treated patients (84 neutropenic episodes) were evaluable. No specific toxicity was no ted. Nine fungal infections developed in the itraconazole group, of wh ich four were histologically or microbiologically proven and 15 in the patients given placebo (eight proven) (p < 0. 12). All these patients received IV amphotericin B. The incidence of Candida albicans infecti ons tended to be lower in the itraconazole group, but overall, there w as no measurable improvement in the prevention of fungal infections an d mortality by itraconazole.