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, Carole B. Miller

*Corresponding author for this work

Research output: Contribution to journalArticle

256 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)296-302
Number of pages7
JournalClinical Infectious Diseases
Volume27
Issue number2
DOIs
StatePublished - Jan 1 1998

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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    White, M. H., Bowden, R. A., Sandler, E. S., Graham, M. L., Noskin, G. A., Wingard, J. R., Goldman, M., Van Burik, J. A., McCabe, A., Lin, J. S., Gurwith, M., & Miller, C. B. (1998). Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatment of fever and neutropenia. Clinical Infectious Diseases, 27(2), 296-302. https://doi.org/10.1086/514672