Journal Article

Randomized, Double-Blind Clinical Trial of Amphotericin B Colloidal Dispersion vs. Amphotericin B in the Empirical Treatment of Fever and Neutropenia

Mary H. White, Raleigh A. Bowden, Eric S. Sandler, Michael L. Graham, Gary A. Noskin, John R. Wingard, Mitchell Goldman, Jo-Anne van Burik, Anne McCabe, Jin-Sying Lin, Marc Gurwith and Carole B. Miller

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 27, issue 2, pages 296-302
Published in print August 1998 | ISSN: 1058-4838
Published online August 1998 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/514672
Randomized, Double-Blind Clinical Trial of Amphotericin B Colloidal Dispersion vs. Amphotericin B in the Empirical Treatment of Fever and Neutropenia

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We conducted a prospective, randomized, double-blind study comparing amphotericin B colloidal dispersion (ABCD) with amphotericin B in the empirical treatment of fever and neutropenia. Patients with neutropenia and unresolved fever after ⩾3 days of empirical antibiotic therapy were stratified by age and concomitant use of cyclosporine or tacrolimus. Patients were then randomized to receive therapy with ABCD (4 mg/[kg·d]) or amphotericin B (0.8 mg/[kg·d]) for ⩽14 days. A total of 213 patients were enrolled, of whom 196 were evaluable for efficacy. Fifty percent of ABCD-treated patients and 43.2% of amphotericin B—treated patients had a therapeutic response (P = .31). Renal dysfunction was less likely to develop and occurred 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 significantly less than that associated with amphotericin B. However, infusion-related events were more common with ABCD treatment than with amphotericin B treatment.

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Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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