A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus In… (NCT04966234) | Clinical Trial Compass
UnknownPhase 2/3
A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection
Czechia, France, Germany135 participantsStarted 2021-04-22
Plain-language 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.
Who can participate
Age range8 Years – 17 Years
SexALL
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Inclusion criteria
✓. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat test and clinical phenotype of lung disease)
✓. Age ≥ 8 yrs and \< 18 yrs
✓. Body weight ≥20 kg
✓. Presence of Aspergillus infection as defined for this study
✓. Clinically stable condition without a significant change in lung function (FEV1 +/- 10%) or significant worsening of respiratory symptoms over the previous month
✓. Able to perform lung function test (FEV1%)
✓. Able to produce a sputum sample (spontaneous or induced sputum)
✓. Informed Consent given
Exclusion criteria
✕. Non-CF lung disorder
✕. Age \< 8 yrs or ≥ 18 yrs
✕
What they're measuring
1
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
2
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
3
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
4
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
5
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
6
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
7
Pharmacokinetic parameters of posaconazole
Timeframe: At steady state, day 5-10 of treatment
8
Aspergillus isolation from sputum cultures
Timeframe: 3 months after randomisation
Trial details
NCT IDNCT04966234
SponsorBambino Gesù Hospital and Research Institute