drugset / Trial / NCT00034645

Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease

NCT00034645 ↗

Phase 3 Completed 600 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindPrevention

Summary

This trial is in high risk patients to determine the safety, tolerance and efficacy of posaconazole (POZ) vs. fluconazole in the prophylaxis against development of invasive fungal infections (IFI).

Timeline

Start
1999-01
Primary completion
2003-02
Completion
2003-02

Outcome

Met primary endpoint

paper At the end of the fixed 112-day treatment period, posaconazole was found to be as effective as fluconazole in preventing all invasive fungal infections PMID 17251530 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Posaconazole Small molecule — Oral