EUCTR2019-003842-34-Outside-EU/EEA进行中（未招募）1 期
A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to <2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection - Posaconazole (MK-5592) IV and oral in children (less than 2 years) with IFI
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Panel A Participants Only
- •1. Is undergoing treatment for possible, probable, or proven IFI known or suspected to be caused by fungal pathogens against which POS has demonstrated activity (which can include candidiasis) per the modified 2008 EORTC/MSG consensus criteria
- •Panel B Participants Only
- •2. Has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be caused by fungal pathogens against which POS has demonstrated activity (see Appendix 8 of the protocol for diagnostic guidance per the modified 2020 EORTC/MSG consensus criteria)
- •Panel A and Panel B Participants
- •3. Has a central line (eg, central venous catheter, peripherally inserted central catheter) in place or planned to be in place before beginning IV study intervention
- •4. Is male or female, from birth to <2 years of age at the time of first dose of study intervention
- •5. Has a body weight of =500 g
- •6. The participant (or legally acceptable representative) has provided documented informed consent for the study
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •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
排除标准
- •Panel A and B Participants
- •1. Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
- •2. Has known or suspected active COVID-19 infection.
- •3. Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used
- •4. Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention
- •5. Has any condition that, in the opinion of the investigator, may interfere with optimal participation in the study
- •Panel B Participants Only
- •6. Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- •7. Has suspected/proven invasive candidiasis.
- •Panel A Participants Only
- •8. Has received any treatment specifically listed in the protocol within the specified time period before the start of study intervention
- •Panel B Participants Only
- •9.Has received any treatment specifically listed in the protocol within the specified time period before the start of study intervention.
- •Panel A and Panel B Participants
- •10. Has enrolled previously in the current study and been discontinued
- •11. Has QTc prolongation (based on either Fridericia or Bazett’s correction) at screening >500 msec
- •12. Has significant liver dysfunction at screening, defined as:
- •- Total bilirubin >1.5 × ULN and AST or ALT >3 × ULN with normal alkaline phosphatase
- •13. Has calculated creatinine clearance <20 mL/min/1.73 m2 (modified Schwartz formula) at screening
- •14. Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
- •15. Has an immediate family member (eg, parent/legal guardian, sibling) who is investigational site or Sponsor staff directly involved with this study
研究者
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