EUCTR2019-004511-31-PT
Active, not recruiting
Phase 1
Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF
Bambino Gesù Children's Hospital0 sites135 target enrollmentJanuary 18, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis and Aspergillus infection.
- Sponsor
- Bambino Gesù Children's Hospital
- Enrollment
- 135
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria for the screening phase:
- •1\. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat
- •test and clinical phenotype of lung disease)
- •2\. Age \= 8 yrs and \< 18 yrs
- •3\. Body weight \= 20 kg
- •4\. Able to produce a sputum sample (spontaneous or induced sputum)
- •5\. Informed Consent given
- •Inclusion criteria for the intervention phase:
- •1\. Diagnosed with cystic fibrosis (genetic diagnosis and/or abnormal sweat
- •test and clinical phenotype of lung disease)
Exclusion Criteria
- •Exclusion criteria for the screening phase:
- •1\. Non\-CF lung disorder
- •2\. Age \< 8 yrs of age or \=18 yrs of age
- •3\. Body weight \< 20 kg
- •4\. Not able to provide sputum sample
- •5\. Informed Consent not given
- •Exclusion criteria for the intervention phase:
- •1\. Non\-CF lung disorder
- •2\. Age \< 8 yrs or \=18 yrs
- •3\. Body weight \< 20 kg
Outcomes
Primary Outcomes
Not specified
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