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Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
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
Who can join
1 Day – 2 Years · All sexes
Full 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
About the study
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).
What is being tested
- Posaconazole IV 6 mg/kg (drug)
- Posaconazole PFS 6 mg/kg (drug)
Sponsor: Merck Sharp & Dohme LLC · Participants: 40 · Started: Feb 22, 2022
Contact the study team
- Toll Free Number · Phone: 1-888-577-8839
Official record on ClinicalTrials.gov — NCT04665037
Locations in the U.S.
| Illinois | Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104), Chicago |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.