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drugset / Trial / NCT03816176

A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants

NCT03816176 ↗

Phase 2 Completed 31 enrolled Astellas Pharma Global Development, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.

Timeline

Start: 2019-08-22
Primary completion: 2022-12-14
Completion: 2022-12-14

Publications

Segers H, Deville JG, Muller WJ, Manzanares A, Desai A, Neely M, Bordon V, Hanisch B, Lassaletta A, Fisher BT, Autmizguine J, Groll AH, Sinnar S, Croos-Dabrera R, Engelhardt M, Jones M, Kovanda LL, Arrieta AC. Safety, outcomes, and pharmacokinetics of isavuconazole as a treatment for invasive fungal diseases in pediatric patients: a non-comparative phase 2 trial. Antimicrob Agents Chemother. 2024 Dec 5;68(12):e0048424. doi: 10.1128/aac.00484-24. Epub 2024 Nov 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Isavuconazonium	Small molecule	10 mg/kg	Intravenous

Indications