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Use of Micafungin for the Prevention and Treatment of Invasive Fungal Infections in Everyday Pediatric Care in France

Results of the MYRIADE Study

Leverger, Guy MD*; Timsit, Jean-François MD, PhD; Milpied, Noël MD, PhD; Gachot, Bertrand MD, PhD§

The Pediatric Infectious Disease Journal: July 2019 - Volume 38 - Issue 7 - p 716–721
doi: 10.1097/INF.0000000000002353
Antimicrobial Reports
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Background: Invasive fungal infections are responsible for significant morbidity and mortality. Safety and effectiveness of antifungal agents is a particular concern in pediatric populations, where data are often limited. Micafungin is an echinocandin with demonstrated antifungal activity against a wide spectrum of Candida spp.; this subanalysis of data from the MYRIADE study describes the use of micafungin and its therapeutic outcomes in pediatric patients, in normal clinical practice.

Methods: MYRIADE was an observational, multicenter, national, prospective, longitudinal study conducted from January 2010 to December 2012, in patients treated with micafungin using a prophylactic or curative strategy, across 17 sites [oncohematology (n = 8), neonatal intensive care units (ICUs) (n = 5) and pediatric ICUs (n = 4)]. The treatment regimen, the achievement of the therapeutic objective and the tolerance were reported.

Results: The study population consisted of 110 pediatric patients (31 neonates, 24 children <2 years old and 55 children ≥2 to <16 years old). The therapeutic objective was achieved in 49/64 (76.6%) oncohematology patients, 28/29 (96.6%) neonatal ICU patients and 12/14 (85.7%) pediatric ICU patients. Twenty-four (21.8%) children developed an adverse event (AE); more AEs were observed in oncohematology patients compared with ICU patients [17 (26.1%) vs. 7 (15.6%)]. Only one serious AE, reported in an oncohematology patient, was considered related to micafungin.

Conclusions: In the first large observational study of micafungin treatment or prophylaxis conducted under real-world conditions in France, micafungin was effective and well tolerated for prophylaxis of invasive fungal infections in pediatric oncohematology patients and for curative purposes in pediatric and neonatal ICU patients.

From the *Assistance Publique des Hôpitaux de Paris, Pediatric Hematology Oncology Unit, Armand Trousseau Hospital

Assistance Publique des Hôpitaux de Paris, Medical and Infectious Diseases Intensive Care Unit, Bichat Hospital, Paris

Hematology Department, Haut-Levèque Hospital, Bordeaux

§Department of Acute Care, Gustave-Roussy Institute—Cancer Campus Grand Paris, Villejuif, France.

Accepted for publication March 10, 2019.

This study was initiated and financial support was provided by Astellas Pharma SAS, Levallois-Perret, France. The academic authors received honoraria from Astellas Pharma Inc. for their contribution to the study, as part of the Steering Committee. Logistical and data management support were performed by CSD Medical Research, and statistical analysis and medical writing support were performed by QUALEES; both funded by Astellas Pharma Inc.

The authors have no conflicts of interest to disclose.

Address for correspondence: Guy Leverger, MD, Hôpital d’Enfants Armand-Trousseau, 26 Avenue du Dr Arnold Netter, 75571 Paris cedex 12, France. E-mail: guy.leverger@aphp.fr.

Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.