PF-Atlas › Клинические испытания › NCT04966234
A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection
Posaconazole 100 MG [Noxafil] · Фаза 2
ID реестра
NCT04966234
Фаза
Фаза 2
Статус
Неизвестно
Препарат / вмешательство
Posaconazole 100 MG [Noxafil]
Спонсор
Bambino Gesù Hospital and Research Institute
Начало
2021-04-22
Набор участников
135
Центры
31
Об исследовании
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.
Связанные материалы
Медицинская оговорка. Эта страница обобщает публичные данные исследования NCT04966234 только для информации. Это не медицинская рекомендация, не одобрение и не предложение участия. Проверяйте детали на ClinicalTrials.gov и у квалифицированного врача.