Prospective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus Infection (cASPerCF)

NCT04966234 Phase 2/Phase 3 UNKNOWN

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.

Details

Lead sponsor	Bambino Gesù Hospital and Research Institute
Phase	Phase 2/Phase 3
Status	UNKNOWN
Enrolment	135
Start date	2021-04-22
Completion	2023-11

Conditions

• Cystic Fibrosis
• Aspergillosis

Interventions

• Posaconazole 100 MG [Noxafil]
• Posaconazole 40 MG/ML

Primary outcomes

• Pharmacokinetic parameters of posaconazole — At steady state, day 5-10 of treatment
  The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Cmax
• Pharmacokinetic parameters of posaconazole — At steady state, day 5-10 of treatment
  The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Cmin
• Pharmacokinetic parameters of posaconazole — At steady state, day 5-10 of treatment
  The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Tmax
• Pharmacokinetic parameters of posaconazole — At steady state, day 5-10 of treatment
  The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Area Under the Curve during 1 dosing interval and over 24 hours
• Pharmacokinetic parameters of posaconazole — At steady state, day 5-10 of treatment
  The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Clearance
• Pharmacokinetic parameters of posaconazole — At steady state, day 5-10 of treatment
  The following pharmacokinetic parameter will be calculated using non-compartmental pharmacokinetic analysis: Distribution volume

Countries

Czechia, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom