At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 149 enrolled
Drug / intervention
isavuconazoledrug
Likely dose
isavuconazole 200 mgfrom 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.
Open-label Study of Isavuconazole in the Treatment of Participants With Aspergillosis and Renal Impairment or of Participants With Invasive Fungal Disease Caused by Rare Moulds, Yeasts or Dimorphic Fungi
In Brief
A Phase 3 clinical trial evaluating isavuconazole for Aspergillosis and Invasive Fungal Infections. Completed, enrolled 149 participants across 96 sites in 19 countries.
Detailed Summary
The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAspergillosis, Invasive Fungal Infections
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, Egypt, France, Germany, India, Israel, Lebanon, Mexico, Poland, Russia, South Africa, South Korea, Thailand, United States
CollaboratorsBasilea Pharmaceutica International Ltd
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2008
Enrollment StartApr 2008
Primary CompletionJan 2014
Study CompletionMay 2016
TodayJul 2026
First PostedMar 12, 2008
Enrollment StartApr 22, 2008
Primary CompletionJan 3, 2014
Study CompletionMay 5, 2016
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 18.3 years ago
Interventions
isavuconazoledrug
Administration of 200 mg isavuconazole 3 times a day in the vein (IV) or oral as a capsule for 2 days, followed by daily administration of 200 mg isavuconazole (IV) or oral