A Study To Evaluate The Safety Of Voriconazole As Treatment Of Invasive Aspergillosis (Fungal Infection) And Other Rare Molds In Children

Phase 3 Terminated 31 enrolled Pfizer

Non-randomizedOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety profile of voriconazole (an antifungal drug) when used in children who have invasive aspergillosis (IA) and other rare systemic fungal infections.

Timeline

Start: 2009-05
Primary completion: 2013-05
Completion: 2013-05

Outcome

Outcome not reported

Stopped (Enrollment): “This protocol terminated prematurely on July 8, 2013 due to slow enrollment, not because of any safety issues or concerns.”

Publications

Martin JM, Macias-Parra M, Mudry P, Conte U, Yan JL, Liu P, Capparella MR, Aram JA. Safety, Efficacy, and Exposure-Response of Voriconazole in Pediatric Patients With Invasive Aspergillosis, Invasive Candidiasis or Esophageal Candidiasis. Pediatr Infect Dis J. 2017 Jan;36(1):e1-e13. doi: 10.1097/INF.0000000000001339.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Voriconazole	Small molecule	4 mg/kg	Intravenous
Subject	Voriconazole	Small molecule	8 mg/kg	Intravenous
Subject	Voriconazole	Small molecule	9 mg/kg	Intravenous
Subject	Voriconazole	Small molecule	200 mg	Intravenous