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Title: A randomized, double-blind, multicenter study of caspofungin versus liposomal amphotericin B for empiric antifungal therapy in pediatric patients with persistent fever and neutropenia
Authors: Maertens, Johan ×
Madero, Luis
Reilly, Anne F
Lehrnbecher, Thomas
Groll, Andreas H
Jafri, Hasan S
Green, Michael
Nania, Joseph J
Bourque, Michael R
Wise, Beth Ann
Strohmaier, Kim M
Taylor, Arlene F
Kartsonis, Nicholas A
Chow, Joseph W
Arndt, Carola A S
DePauw, Ben E
Walsh, Thomas J #
Issue Date: May-2010
Publisher: Williams & Wilkins
Series Title: The Pediatric Infectious Disease Journal vol:29 issue:5 pages:415-420
Abstract: BACKGROUND: Persistently febrile neutropenic children at risk for invasive fungal infections receive empiric antifungal therapy as a standard of care. However, little is known about the role of echinocandins and liposomal amphotericin B (L-AmB) for empiric antifungal therapy in pediatric patients. METHODS: Patients between the ages of 2 to 17 years with persistent fever and neutropenia were randomly assigned to receive caspofungin (70 mg/m loading dose on day 1, then 50 mg/m daily [maximum 70 mg/d]) or L-AmB (3 mg/kg daily) in a 2:1 ratio. Evaluation of safety was the primary objective of the study. Efficacy was also evaluated, with a successful outcome defined as fulfilling all components of a prespecified 5-part composite endpoint. Suspected invasive fungal infections were evaluated by an independent, treatment-blinded adjudication committee. RESULTS: Eighty-two patients received study therapy (caspofungin 56, L-AmB 26), and 81 were evaluated for efficacy (caspofungin 56; L-AmB 25). Outcomes for safety and efficacy endpoints were similar for both study arms. Adverse drug-related event rates [95% confidence interval] were similar between the caspofungin and L-AmB groups (clinical 48.2% [34.7-62.0] versus 46.2% [26.6-66.6]; laboratory 10.7% [4.0-21.9] versus 19.2% [6.6-39.4]). Serious drug-related adverse events occurred in 1 (1.8%) of caspofungin-treated patients and 3 (11.5%) of L-AmB-treated patients. Overall success rates [95% CI] were 46.4% [33.4-59.5] for caspofungin and 32.0% [13.7-50.3] for L-AmB. CONCLUSIONS: Caspofungin and L-AmB were comparable in tolerability, safety, and efficacy as empiric antifungal therapy for persistently febrile neutropenic pediatric patients.
URI: 
ISSN: 0891-3668
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Hematology Section (-)
Department of Microbiology & Immunology - miscellaneous
× corresponding author
# (joint) last author

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