drugset / Trial / NCT04876716

Azole-echinocandin Combination Therapy for Invasive Aspergillosis

NCT04876716

RandomizedParallel-groupOpen-labelTreatment

Summary

The goals of this study are 3-fold: First, the main study and the primary endpoint will evaluate if the overall mortality can be decreased with initial azole-echinocandin combination therapy compared with triazole monotherapy in patients with IA and documented voriconazole susceptibility. Second, the study design described will also allow to study several other subpopulations; Indeed, the outcome of the following subgroups will be evaluated as well; a. Patients starting azole monotherapy but who switch to directed therapy when it has become clear that the infection is caused by an azole resistant A. fumigatus. b. patients in which eventually no resistance data become available in relation to the treatment they received. Third, the study will evaluate what the outcome is of patients that turn out to be infected with a triazole resistant A. fumigatus who started with a triazole-echinocandin combination therapy.

Timeline

Start
2021-05-11
Primary completion
2024-05-01
Completion
2024-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Anidulafungin Other / unclassified 100 mg Intravenous
Background Isavuconazole Small molecule Intravenous
Background Posaconazole Small molecule Intravenous
Background Voriconazole Small molecule Intravenous