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.
Age range
8 Years – 17 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
Aspergillus isolation from sputum cultures
Timeframe: 3 months after randomisation