Efficacy of pre-emptive versus empirical antifungal therapy in children with cancer and high-risk febrile neutropenia: a randomized clinical trial

To compare the efficacy of pre-emptive versus empirical antifungal therapy in children with cancer, fever and neutropenia. This was a prospective, multicentre, randomized clinical trial. Children presenting with persistent high-risk febrile neutropenia at five hospitals in Santiago, Chile, were rand...

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Published in:Journal of antimicrobial chemotherapy 2018-10, Vol.73 (10), p.2860-2866
Main Authors: Santolaya, María E, Alvarez, Ana M, Acuña, Mirta, Avilés, Carmen L, Salgado, Carmen, Tordecilla, Juan, Varas, Mónica, Venegas, Marcela, Villarroel, Milena, Zubieta, Marcela, Farfán, Mauricio, de la Maza, Verónica, Vergara, Alejandra, Valenzuela, Romina, Torres, Juan P
Format: Article
Language:English
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Summary:To compare the efficacy of pre-emptive versus empirical antifungal therapy in children with cancer, fever and neutropenia. This was a prospective, multicentre, randomized clinical trial. Children presenting with persistent high-risk febrile neutropenia at five hospitals in Santiago, Chile, were randomized to empirical or pre-emptive antifungal therapy. The pre-emptive group received antifungal therapy only if the persistent high-risk febrile neutropenia was accompanied by clinical, laboratory, imaging or microbiological pre-defined criteria. The primary endpoint was overall mortality at day 30 of follow-up. Secondary endpoints included invasive fungal disease (IFD)-related mortality, number of days of fever, days of hospitalization and use of antifungal drugs, percentage of children developing IFD, requiring modification of initial treatment strategy and need for ICU. The trial was registered with Registro Brasileiro de Ensaios Cl쭩cos (ReBEC) under trial number RBR-3m9d74. A total of 149 children were randomized, 73 to empirical therapy and 76 to pre-emptive therapy. Thirty-two out of 76 (42%) children in the pre-emptive group received antifungal therapy. The median duration of antifungal therapy was 11 days in the empirical arm and 6 days in the pre-emptive arm (P 
ISSN:0305-7453
1460-2091
DOI:10.1093/jac/dky244