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

• Status: Recruiting
• Trial end date: 2023-07-31
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants <2 years of age with invasive fungal infection (IFI).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Posaconazole

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 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