RANDOMIZED, DOUBLE-BLIND CLINICAL-TRIAL OF AMPHOTERICIN-B COLLOIDAL DISPERSION VS. AMPHOTERICIN-B IN THE EMPIRICAL-TREATMENT OF FEVER AND NEUTROPENIA

We conducted a prospective, randomized, double-blind study comparing a mphotericin B colloidal dispersion (ABCD) with amphotericin B in the e mpirical treatment of fever and neutropenia. Patients with neutropenia and unresolved fever after greater than or equal to 3 days of empiric al antibiotic therapy were stratified by age and concomitant use of cy closporine or tacrolimus. Patients were then randomized to receive the rapy with ABCD (4 mg/[kg.d]) or amphotericin B (0.8 mg/[kg.d]) for les s than or equal to 14 days. A total of 213 patients were enrolled, of whom 196 were evaluable for efficacy, Fifty percent of ABCD-treated pa tients and 43.2% of amphotericin B-treated patients had a therapeutic response (P = .31). Renal dysfunction was less likely to develop and o ccurred later in ABCD recipients than in amphotericin B recipients (P < .001 for both parameters). Infusion-related hypoxia and chills were more common in ABCD recipients than in amphotericin B recipients (P = .013 and P = .018, respectively). ABCD appeared comparable in efficacy with amphotericin B, and renal dysfunction associated with ABCD was s ignificantly less than that associated with amphotericin B. However, i nfusion-related events were more common with ABCD treatment than with amphotericin B treatment.