Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)

This is an interventional treatment trial for Invasive Fungal Infection Read More

Inclusion Criteria:

• Panel A: Is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis)
• Panel B: has a 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)
• If enrolled with a possible or probable IFI diagnosis, has one or more of the listed host factors
• If enrolled with a possible or probable IFI diagnosis, meets listed criteria
• If enrolled with a proven IFI diagnosis, sampling of normally sterile tissue has shown fungal elements by cytology or microscopy, or sampling of normally sterile tissue or blood has yielded a positive culture for a fungal pathogen
• Has clinical symptoms consistent with an acute episode of IFI, defined as duration of clinical syndrome of <30 days.
• 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.

Exclusion Criteria

• Has received POS within 30 days before Day 1
• 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 chronic (≥30 days' duration) IFI, relapsed/recurrent IFI, or refractory IFI that has not responded to prior antifungal treatment
• 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 known or suspected Gilbert disease
• 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 (Part B)
• Has invasive candidiasis (Part B)
• 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