A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection
Status:
Recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
This study will provide: (1) new insights in the prevalence of Aspergillus infection in
children and adolescents with CF aged 8-17 yrs; (2) an in silico modelled dose of
posaconazole for children and adolescents with CF and Aspergillus infection aged 8-17 yrs;
(3) an intensive sampling PK study to define the optimal dose in a limited number of children
and adolescents with CF and Aspergillus infection aged 8-17 yrs; (4) a prospective clinical
validation to reduce the residual variability and to allow investigation into PK-PD; and (5)
an efficacy evaluation of this dosing regimen to treat Aspergillus infection in children and
adolescents with CF to inform future primary efficacy trials.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Bambino Gesù Hospital and Research Institute
Collaborators:
Consorzio per Valutazioni Biologiche e Farmacologiche Radboud University University of Exeter