NL-OMON54920撤回2 期
Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection - A new posaconazole dosing regimen for children with cystic fibrosis
IRCCS Ospendale Pediatrico Bambino Gesu0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 18
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •135 children and adolescents will be included. We strive to include 45 children
- •each in the following weight bands: 20-30 kg; 30-40 kg; >40 kg body weight
- •Inclusion criteria for the screening phase of the study (n<=1500):
- •Subjects must meet the following criteria to be eligible for participation in
- •the screening phase:
- •1. Diagnosed with CF (genetic diagnosis and/or abnormal sweat test and clinical
- •phenotype of lung disease).
- •2. Age * 8 yrs and < 18 yrs.
- •3. Able to produce sputum sample (spontaneous or induced sputum).
- •4. Informed Consent given.
- •Inclusion criteria for the posaconazole trial
- •1. Diagnosed with CF (genetic diagnosis and clinical phenotype of lung disease).
- •2. Age * 8 yrs and < 18 yrs.
- •3. Body weight *20 kg
- •4. Signs 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 in the month
- •preceding signing of the ICF
- •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
排除标准
- •Exclusion criteria for the screening phase of the study (n=1500):
- •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 posaconazole trial (n=135)
- •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. Pregnancy2 or breastfeeding
- •23. Females of childbearing age who do not intend to use contraception measures.
- •24. Informed Consent not given
研究者
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