EUCTR2019-004511-31-IT
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
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA0 sites135 target enrollmentOctober 7, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis and Aspergillus infection.
- Sponsor
- IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA
- Enrollment
- 135
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
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 clinical phenotype of lung disease)
- •2\. Age \= 8 yrs and \< 18 yrs
- •3\. Able to produce a sputum sample (spontaneous or induced sputum)
- •4\. 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)
- •2\. Age \= 8 yrs and \< 18 yrs
- •3\. Presence of Aspergillus infection as defined for this study
- •4\. Clinically stable condition without a significant change in lung function (FEV1 \+/\- 10%) or significant worsening of respiratory symptoms over the previous month
Exclusion Criteria
- •Exclusion criteria for the trial:
- •1\. Age \< 8 yrs or \= 18 yrs
- •2\. Unable to perform lung function test (FEV1\)
- •3\. Unable to produce a sputum sample (spontaneous or induced sputum)
- •4\. Clinically unstable condition with significant change in lung function or significant worsening of respiratory symptoms
- •5\. Unable to tolerate oral medication
- •6\. Known hypersensitivity to the drug/excipients
- •7\. On active transplant list or transplant recipient
- •8\. Azole resistant Aspergillus sp. cultured
- •9\. Patients receiving terfenadine, ergot alkaloids, astemizole, cisapride, pimozide, halofantrine, quinidine, or HMG\-CoA reductase inhibitors metabolised through CYP3A4
Outcomes
Primary Outcomes
Not specified
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