Journal Article

Aerosolized Liposomal Amphotericin B for the Prevention of Invasive Pulmonary Aspergillosis during Prolonged Neutropenia: A Randomized, Placebo-Controlled Trial

Bart J. Rijnders, Jan J. Cornelissen, Lennert Slobbe, Martin J. Becker, Jeanette K. Doorduijn, Wim C. J. Hop, Elisabeth J. Ruijgrok, Bob Lüwenberg, Arnold Vulto, Pieternella J. Lugtenburg and Siem de Marie

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 46, issue 9, pages 1401-1408
Published in print May 2008 | ISSN: 1058-4838
Published online May 2008 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/586739
Aerosolized Liposomal Amphotericin B for the Prevention of Invasive Pulmonary Aspergillosis during Prolonged Neutropenia: A Randomized, Placebo-Controlled Trial

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Background. Invasive pulmonary aspergillosis (IPA) is a significant problem in patients with chemotherapy-induced prolonged neutropenia. Because pulmonary deposition of conidia is the first step in developing IPA, we hypothesized that inhalation of liposomal amphotericin B would prevent IPA.

Methods. We performed a randomized, placebo-controlled trial of patients with hematologic disease with expected neutropenia for ⩾10 days. Patients were randomized to receive liposomal amphotericin B or placebo inhalation twice a week, using an adaptive aerosol delivery system, until neutrophil counts increased to >300 cells/mm3. In subsequent neutropenic episodes, the assigned treatment was restarted. The primary end point was the occurrence of IPA according to European Organization for Research and the Treatment of Cancer-Mycoses Study Group definitions. Kaplan-Meier curves were compared with log-rank tests for intent-to-treat and on-treatment populations.

Results. A total of 271 patients were studied during 407 neutropenic episodes. According to the intent-to-treat analysis, 18 of 132 patients in the placebo group developed IPA versus 6 of 139 patients in the liposomal amphotericin B group (odds ratio, 0.26; 95% confidence interval, 0.09–0.72; P=.005). According to the on-treatment analysis, 13 of 97 patients receiving placebo versus 2 of 91 receiving liposomal amphotericin B developed IPA (odds ratio, 0.14; 95% confidence interval, 0.02–0.66; P=.007). Some adverse effects, but none serious, in the liposomal amphotericin B group were reported, most frequently coughing (16 patients vs. 1 patient; P=.002).

Conclusion. In high-risk patients, prophylactic inhalation of liposomal amphotericin B significantly reduced the incidence of IPA.

Journal Article.  4121 words.  Illustrated.

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

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