Treatment will begin on Day 1 and then participants will be followed for 60 days post-last dose for safety. Treatment will be administered until the participant has a successful outcome or for a maximum duration of 84 days (IA) or 180 days (IM), whichever occurs first.~Participants will receive a loading regimen of isavuconazonium sulfate (via intravenous or oral administration at the investigator's discretion), which consists of a dose every 8 hours (± 2 hours) on Days 1 and 2 (for a total of 6 doses), followed by once daily maintenance dosing for up to 84 days (IA) or 180 days (IM) of dosing. The first maintenance dose should start 12 to 24 hours after the administration of the last loading dose. Subsequent maintenance doses will be administered once daily (24 hours ± 2 hours from the previous maintenance dose). The oral formulation can only be given to subjects 6 years to < 18 years of age and with a body weight of at least 12 kg. Subjects who are discharged from the hospital with oral capsules for at-home administration must return weekly for study drug accountability and to receive new oral dosing supplies. Subjects who begin oral administration are to complete the oral dosing acceptability assessment after ingesting their first oral dose.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.