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ongoing trials trial from www.clinicaltrials.gov

A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection - Phase 2|Phase 3 - Recruiting

  • Year: 2021
  • Date: April 22, 2021
  • Author: Bambino Gesù Hospital and Research Institute|University of Exeter|Radboud University|Consorzio per Valutazioni Biologiche e Farmacologiche
Source

https://ClinicalTrials.gov/show/NCT04966234

Study design (if review, criteria of inclusion for studies)

Interventional - Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment

Participants

Cystic Fibrosis|Aspergillosis - 8 Years to 17 Years   (Child)

Interventions

Drug: Posaconazole 100 MG [Noxafil]|Drug: Posaconazole 40 MG/ML

Outcome measures

Pharmacokinetic parameters of posaconazole|Aspergillus isolation from sputum cultures|Patients with a favourable clinical response and no signs of Aspergillus infection|Patients with no signs of Aspergillus infection|The proportion of participants experiencing AEs and SAEs

Keywords: Adolescent; Adult; Antifungal Agents; Child; pharmacological_intervention; Allergic Bronchopulmonary Aspergillosis -ABPA-; Aspergillus; Fungi; Infection; Respiratory Tract Infections; Respiratory Tract Diseases; posaconazole;