title: A double-blind, randomized, controlled trial of amphotericin B colloidal dispersion versus amphotericin B for treatment of invasive aspergillosis in immunocompromised patients.
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.
authors.affiliation: Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors.forename: Raleigh
authors.initials: R
authors.lastname: Bowden
authors.forename: Pranatharthi
authors.initials: P
authors.lastname: Chandrasekar
authors.forename: Mary H
authors.initials: MH
authors.lastname: White
authors.forename: Xin
authors.initials: X
authors.lastname: Li
authors.forename: Larry
authors.initials: L
authors.lastname: Pietrelli
authors.forename: Marc
authors.initials: M
authors.lastname: Gurwith
authors.forename: Jo-Anne
authors.initials: JA
authors.lastname: van Burik
authors.forename: Michel
authors.initials: M
authors.lastname: Laverdiere
authors.forename: Sharon
authors.initials: S
authors.lastname: Safrin
authors.forename: John R
authors.initials: JR
authors.lastname: Wingard
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000666:Amphotericin B / Q000009:adverse effects / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001228:Aspergillosis / Q000188:drug therapy* / Q000401:mortality; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D016503:Drug Delivery Systems; D006801:Humans; D016867:Immunocompromised Host; D008875:Middle Aged; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D000666:Amphotericin B