EUCTR2019-004511-31-ITActive, not recruitingPhase 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 enrollmentStarted: October 7, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 135
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •5. Able to perform lung function test (FEV1)
- •6. Able to produce a sputum sample (spontaneous or induced sputum)
- •7. Informed Consent given
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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
- •10. Patients receiving omalizumab
- •11. Received systemic mould-active antifungals in the last month
- •12. Shortened or elongated QT interval
- •13. Cardiac failure
- •14. ALT = 200 U/L
- •15. AST = 225 U/L
- •16. Alkaline phosphatase = 460 U/L
- •17. Bilirubin = 50 umol/L
- •18. Pregnancy
- •19. Informed Consent not given
Investigators
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