A randomized, double-blind comparative trial evaluating the safety of liposomal amphotericin B versus amphotericin B lipid complex in the empirical treatment of febrile neutropenia. L Amph/ABLC Collaborative Study Group

Clin Infect Dis. 2000 Nov;31(5):1155-63. doi: 10.1086/317451. Epub 2000 Nov 7.

Abstract

In this double-blind study to compare safety of 2 lipid formulations of amphotericin B, neutropenic patients with unresolved fever after 3 days of antibacterial therapy were randomized (1:1:1) to receive amphotericin B lipid complex (ABLC) at a dose of 5 mg/kg/d (n=78), liposomal amphotericin B (L Amph) at a dose of 3 mg/kg/d (n=85), or L Amph at a dose of 5 mg/kg/d (n=81). L Amph (3 mg/kg/d and 5 mg/kg/d) had lower rates of fever (23.5% and 19.8% vs. 57.7% on day 1; P<.001), chills/rigors (18.8% and 23.5% vs. 79.5% on day 1; P<.001), nephrotoxicity (14.1% and 14.8% vs. 42.3%; P<.01), and toxicity-related discontinuations of therapy (12.9% and 12.3% vs. 32.1%; P=.004). After day 1, infusional reactions were less frequent with ABLC, but chills/rigors were still higher (21.0% and 24.3% vs. 50.7%; P<.001). Therapeutic success was similar in all 3 groups.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amphotericin B / adverse effects
  • Amphotericin B / therapeutic use*
  • Antifungal Agents / adverse effects
  • Antifungal Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Chills / chemically induced
  • Double-Blind Method
  • Drug Carriers
  • Female
  • Fever / chemically induced
  • Humans
  • Infusions, Intravenous
  • Liposomes
  • Male
  • Middle Aged
  • Mycoses / prevention & control*
  • Nausea / chemically induced
  • Neutropenia / drug therapy*
  • Neutropenia / mortality
  • Survival Rate
  • Vomiting / chemically induced

Substances

  • Antifungal Agents
  • Drug Carriers
  • Liposomes
  • Amphotericin B