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 Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection - MK-5592-127

Merck Sharp & Dohme LLC0 个研究点目标入组 32 人开始时间: 2024年3月5日最近更新: 2024年8月21日

研究概览

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•Panel A: Is undergoing treatment for possible, probable, or proven invasive fungal infection (IFI) known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis), Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis), 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, Has a body weight of =500 g, The participant (or legally acceptable representative) has provided documented informed consent for the study.

•Has received POS within 30 days before Day 1, Has enrolled previously in the current study and been discontinued, Has QTc prolongation at screening >500 msec, Has significant liver dysfunction, Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days, Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis., Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, Has known or suspected active COVID-19 infection, Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used, Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention, Has received any listed prohibited medications within the specified timeframes before the start of study intervention, Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (Panel B), Has suspected/proven invasive candidiasis (Panel B)

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