PF-AtlasКлинические 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.

Открыть NCT04966234 на ClinicalTrials.gov →

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.