drugset / Trial / NCT00075803

Comparison of Fluconazole vs Voriconazole to Treat Fungal Infections for Blood and Marrow Transplants (BMT CTN 0101)

NCT00075803

RandomizedParallel-groupDouble-blindTreatment

Summary

The study is designed as a Phase III, randomized, double-blind, multicenter, prospective, comparative study of fluconazole versus voriconazole for the prevention of fungal infections in allogeneic transplant recipients. Recipients will be stratified by center and donor type (sibling vs. unrelated) and will be randomized to either the fluconazole or voriconazole arm in a 1:1 ratio.

Timeline

Start
2003-11
Primary completion
2006-09
Completion
2007-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluconazole Small molecule 400 mg Oral
Subject Voriconazole Small molecule 4 mg/kg Oral
Subject Voriconazole Small molecule 200 mg Oral