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Aerosolized amphotericin B inhalations as prophylaxis of invasive aspergillus infections during prolonged neutropenia: results of a prospective randomized multicenter trial

Item Type:Article
Title:Aerosolized amphotericin B inhalations as prophylaxis of invasive aspergillus infections during prolonged neutropenia: results of a prospective randomized multicenter trial
Creators Name:Schwartz, S. and Behre, G. and Heinemann, V. and Wandt, H. and Schilling, E. and Arning, M. and Trittin, A. and Kern, W.V. and Boenisch, O. and Bosse, D. and Lenz, K. and Ludwig, W.D. and Hiddemann, W. and Siegert, W. and Beyer, J.
Abstract:We performed a prospective, randomized, multicenter trial to evaluate the effectiveness of prophylactic inhalations with aerosolized amphotericin B (aeroAmB) to reduce the incidence of invasive aspergillus (IA) infections in patients after chemotherapy or autologous bone marrow transplantation and an expected duration of neutropenia of at least 10 days. From March 1993 until April 1996, 382 patients with leukemias, relapsed high-grade non-Hodgkin lymphomas, or solid tumors were randomized with a 13:10 ratio to receive either prophylactic aeroAmB inhalations at a dose of 10 mg twice daily or no inhalation prophylaxis in an unblinded fashion. The incidence of proven, probable, or possible IA infections was 10 of 227 (4%) in patients who received prophylactic aeroAmB. This did not differ significantly from the 11 of 155 (7%) incidence in patients who received no inhalation prophylaxis (P = .37). Moreover, no differences in the overall mortality (13% v 10%; P= .37) or in the infection-related mortality (8% v 7%;P = .79) were found. In contrast to other nonrandomized trials, we observed no benefit from prophylactic aeroAmB inhalations, but the overall incidence of IA infections was low.
Keywords:Amphotericin B, Antifungal Agents, Antineoplastic Combined Chemotherapy Protocols, Aspergillosis, Aspergillus, Autologous Transplantation, Bone Marrow Transplantation, Combined Modality Therapy, Inhalation Administration, Leukemia, Neoplasms, Non-Hodgkin Lymphoma, Prospective Studies, Recurrence, Treatment Outcome
Source:Blood
ISSN:0006-4971
Publisher:American Society of Hematology (U.S.A.)
Volume:93
Number:11
Page Range:3654-3661
Date:1 June 1999
Official Publication:http://bloodjournal.hematologylibrary.org/cgi/content/abstract/93/11/3654
PubMed:View item in PubMed

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