Journal Article

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 and John R Wingard

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 35, issue 4, pages 359-366
Published in print August 2002 | ISSN: 1058-4838
Published online August 2002 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/341401
A Double-Blind, Randomized, Controlled Trial of Amphotericin B Colloidal Dispersion versus Amphotericin B for Treatment of Invasive Aspergillosis in Immunocompromised Patients

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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

Journal Article.  5199 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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