A double-blind, randomized, controlled trial of amphotericin B colloidal dispersion versus amphotericin B for treatment of invasive aspergillosis in immunocompromised patients

Raleigh Bowden, Pranatharthi Chandrasekar, Mary H. White, Xin Li, Larry Pietrelli, Marc Gurwith, Jo Anne Van Burik, Michel Laverdiere, Sharon Safrin, John R. Wingard

Research output: Contribution to journalArticle

262 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)359-366
Number of pages8
JournalClinical Infectious Diseases
Volume35
Issue number4
DOIs
StatePublished - Aug 15 2002

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