CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 450 enrolled
Drug / intervention
Isavuconazole +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00413218
NCT00413218Phase 3Completed

A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections

Astellas Pharma Inc·interventional·Posted Dec 19, 2006·Updated Dec 10, 2024

In Brief

A Phase 3 clinical trial evaluating Isavuconazole, Caspofungin, and 1 other intervention for Candidiasis, Invasive and 2 related conditions. Completed, enrolled 450 participants across 113 sites in 25 countries.

Detailed Summary

The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, China, France, Germany, Hungary, India, Israel, Italy, Lebanon, Malaysia, Mexico, New Zealand, Philippines, Russia, Singapore, South Africa, Spain, Switzerland, Thailand, United States

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2006
Enrollment StartMar 8, 2007
Primary CompletionMar 3, 2015
TodayJul 2, 2026
Enrollment to primary: 8.0 yearsPosted 19.5 years ago

Interventions

Isavuconazoledrug

Administered by intravenous infusion.

Caspofungindrug

Administered by intravenous infusion.

Voriconazoledrug

Administered by intravenous infusion.