A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients

Phase 3 Terminated 23 enrolled Pfizer

Non-randomizedOpen-labelTreatment

Summary

The purpose of this study is to determine whether voriconazole is safe and effective for the treatment of serious Candida infection and Candida infection of the esophagus in children and adolescents.

Timeline

Start: 2010-10
Primary completion: 2013-05
Completion: 2013-06

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	3 mg/kg	Intravenous
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

A Study Of The Safety, Tolerability And Effective Of Voriconazole For The Treatment Of Serious Candida Infection And Candida Infection Of The Throat In Pediatric Patients

Summary

Timeline

Publications

Drugs

Indications