Real-World Comparison of Isavuconazole and Voriconazole in Terms of the Need for Dosage Adjustments Guided by Clinical Pharmacological Advice During Primary Prophylaxis of Invasive Fungal Infections in Pediatric Patients with Hemato-Oncological Malignancies

*Department of Medical and Surgical Sciences, Alma Mater Studiorum, University of Bologna, Bologna, Italy;

†Clinical Pharmacology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy;

‡Infectious Diseases Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; and

§Pediatric Oncology and Hematology Unit “Lalla Seràgnoli,” IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.

Correspondence: Milo Gatti, MD, Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, SSD Clinical Pharmacology, IRCCS Azienda Ospedaliero–Universitaria di Bologna, Via Massarenti 9, Bologna 40138, Italy. (e-mail: [email protected]).

M. Gatti reports grants from Angelini S.p.A. outside the submitted work. F. Pea reports personal fees from Angelini, Basilea Pharmaceutica, Gilead, Hikma, MSD, Pfizer, Sanofi–Aventis, Shionogi, Thermo Fisher, and Accelerate Diagnostics outside the submitted work, has participated in speaker's bureaus for Accelerate Diagnostics, Angelini, Basilea Pharmaceutica, Gilead, Hikma, MSD, Pfizer, Sanofi-Aventis, Shionogi, Thermo Fisher, and has served as consultants for Angelini, Basilea Pharmaceutica, Gilead, MSD, Pfizer, and Shionogi outside the submitted work. P. Viale has served as a consultant for bioMérieux, Gilead, Merck Sharp & Dohme, Nabriva, Nordic Pharma, Pfizer, Thermo Fisher, and Venatorx and received payment for serving on speaker's bureaus for Correvio, Gilead, Merck Sharp & Dohme, Nordic Pharma, and Pfizer outside the submitted work. The other authors declare no potential conflicts of interest related to this study.

This study was reviewed and approved by the Ethics Committee of the Azienda Ospedaliero–Universitaria di Bologna (No. 443/2021/Oss/AOUBo). Ethics Committee approval and written informed consent were obtained on a single-patient basis for the off-label use of isavuconazole.

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