A Double-Blind, Randomized, Controlled Trial of Amphotericin B Colloidal Dispersion Versus Amphotericin B for Treatment of Invasive Aspergillosis in Immunocompromised Patients

Clin Infect Dis. 2002 Aug 15;35(4):359-66. doi: 10.1086/341401. Epub 2002 Jul 25.

Abstract

We report a randomized, double-blind, multicenter trial in which amphotericin B colloidal dispersion (ABCD [Amphotec]; 6 mg/kg/day) was compared with amphotericin B (AmB; 1.0-1.5 mg/kg/day) for the treatment of invasive aspergillosis in 174 patients. For evaluable patients in the ABCD and AmB treatment groups, respective rates of therapeutic response (52% vs. 51%; P=1.0), mortality (36% vs. 45%; P=.4), and death due to fungal infection (32% vs. 26%; P=.7) were similar. Renal toxicity was lower (25% vs. 49%; P=.002) and the median time to onset of nephrotoxicity was longer (301 vs. 22 days; P<.001) in patients treated with ABCD. Rates of drug-related toxicity in patients receiving ABCD and AmB, respectively, were 53% versus 30% (chills), 27% versus 16% (fever), 1% versus 4% (hypoxia) and 22% versus 24% (toxicity requiring study drug discontinuation). ABCD appears to have equivalent efficacy and superior renal safety, compared with AmB, in the treatment of invasive aspergillosis. However, infusion-related chills and fever occurred more frequently in patients receiving ABCD than in those receiving AmB.

Publication types

  • Clinical Trial
  • 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*
  • Aspergillosis / drug therapy*
  • Aspergillosis / mortality
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Drug Delivery Systems
  • Humans
  • Immunocompromised Host
  • Middle Aged
  • Treatment Outcome

Substances

  • Antifungal Agents
  • Amphotericin B