PF-Atlas › Clinical Trials › NCT04966234
A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection
Posaconazole 100 MG [Noxafil] · Phase 2
Registry ID
NCT04966234
Phase
Phase 2
Status
Unknown
Drug / intervention
Posaconazole 100 MG [Noxafil]
Sponsor
Bambino Gesù Hospital and Research Institute
Start
2021-04-22
Enrollment
135
Locations
31
About this trial
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.
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Medical disclaimer. This page summarizes public trial data for NCT04966234 for information only. It is not medical advice, an endorsement, or an offer to enroll. Confirm details on ClinicalTrials.gov and with a qualified physician.