EUCTR2019-004511-31-GBActive, 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
Bambino Gesù Children's Hospital0 sites135 target enrollmentStarted: October 6, 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/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)
- •2. Age = 8 yrs and < 18 yrs
- •3. Body weight = 20 kg
- •4. Presence of Aspergillus infection as defined for this study
- •5. Clinically stable condition without a significant change in lung function (FEV1 +/- 10%) or significant worsening of respiratory symptoms over the previous month
- •6. Able to perform lung function test (FEV1%)
- •7. Able to produce a sputum sample (spontaneous or induced sputum)
- •8. Informed Consent given
- •9. If female and of childbearing age must be using highly effective contraception (and must agree to continue for 7 days after the last dose of investigational medicinal product [IMP]) [1[
- •Footnote: [1] Highly effective contraception is defined as one of the following: combined (estrogen and progestogen containing) hormonal
- •contraception associated with inhibition of ovulation (oral, injectable or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable); intrauterine device (IUD); intrauterine hormone-releasing system ( IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence (defined as refraining from heterosexual intercourse when it is in line with the preferred and usual lifestyle of the subject)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 135
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
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
- •4. Not able to perform lung function test (FEV1%)
- •5. Unable to produce a sputum sample (spontaneous or induced sputum)
- •6. Clinically unstable condition with significant change in lung function or significant worsening of respiratory symptoms
- •7. Unable to tolerate oral medication
- •8. Known hypersensitivity to itraconazole or posaconazole, or it’s excipients.
- •9. On active transplant list or transplant recipient
- •10. Azole resistant Aspergillus sp. cultured
- •11. Patients receiving terfenadine, ergot alkaloids, astemizole, cisapride, pimozide, halofantrine, quinidine, or HMG-CoA reductase inhibitors metabolised through CYP3A4 (eg. simvastatin, lovastatin, and atorvastatin)
- •12. Patients receiving omalizumab
- •13. Received systemic mould-active antifungals in the last month
- •14. Shortened or elongated QT interval
- •15. Cardiac failure
- •16. ALT = 200 U/L
- •17. AST = 225 U/L
- •18. Alkaline phosphatase = 460 U/L
- •19. Bilirubin = 50 umol/L
- •20. eGFR < 20 ml/min/1.73 m2 (calculated with the Schwartz formula)
- •21. Patients with known glucose-galactose malabsorption problems
- •22. Pregnancy [2] or breastfeeding
- •23. Females of childbearing age who do not intend to use contraception measures.
- •24. Informed Consent not given
- •Footnote: [2] For females of child bearing age this must be confirmed by a pregnancy test within 10 days prior to randomizatio
Investigators
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