Randomized, double-blind clinical trial of amphotericin B colloidal dispersion vs. amphotericin B in the empirical treatment of fever and neutropenia

Clin Infect Dis. 1998 Aug;27(2):296-302. doi: 10.1086/514672.

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 > or = 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 < or = 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Amphotericin B / administration & dosage*
  • Amphotericin B / therapeutic use
  • Antifungal Agents / administration & dosage*
  • Antifungal Agents / therapeutic use
  • Child
  • Child, Preschool
  • Colloids
  • Cyclosporine
  • Double-Blind Method
  • Female
  • Fever / complications
  • Fever / immunology*
  • Humans
  • Immunosuppressive Agents
  • Infant
  • Infusions, Intravenous
  • Kidney Function Tests
  • Male
  • Middle Aged
  • Mycoses / prevention & control*
  • Neutropenia / complications
  • Neutropenia / immunology*
  • Opportunistic Infections / prevention & control*
  • Pilot Projects
  • Prospective Studies
  • Tacrolimus
  • Treatment Outcome

Substances

  • Antifungal Agents
  • Colloids
  • Immunosuppressive Agents
  • Amphotericin B
  • Cyclosporine
  • Tacrolimus