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

Launched by MERCK SHARP & DOHME LLC · Dec 9, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a medication called posaconazole, which is used to treat invasive fungal infections in children under 2 years old. The researchers want to understand how the body processes this medication when given either through an intravenous (IV) line or as an oral powder that can be mixed with liquid. This is important because young children may react differently to medications than adults. The study is currently looking for participants who are being treated for certain fungal infections and who have a central line for medication delivery.

To be eligible for this trial, children must weigh at least 500 grams and have a diagnosis of a fungal infection that posaconazole can help treat. However, there are some criteria that would exclude a child from participating, such as having certain health conditions or recent infections. Families who choose to participate will need to provide consent, and they can expect close monitoring during the study to ensure the medication is safe and effective for their child. This trial is a step toward better understanding how to treat young children with serious fungal infections.

Gender

ALL

Eligibility criteria

• 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 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.
• • 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 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 (Part B)
• • Has suspected/proven 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