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

  • End date
    Jul 31, 2023
  • participants needed
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 27 October 2021
Toll Free Number
Primary Contact
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601) (2.5 mi away) Contact
+12 other location


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).


There are 2 panels in this study. In Panel A, POS IV will be evaluated in 8 participants, including 5 who are <3 months of age and 3 who are 3 months to <2 years of age. In Panel B, both POS IV and POS PFS will be evaluated in 14 participants, including 3 who are <3 months of age and 5 who transition to the PFS formulation of POS.

Condition Mycoses, Systemic Fungal Infections, Invasive Fungal Infection, Invasive Fungal Infections, Fungal Infections
Treatment Posaconazole IV 6 mg/kg, Posaconazole IV TBD, Posaconazole PFS TBD
Clinical Study IdentifierNCT04665037
SponsorMerck Sharp & Dohme Corp.
Last Modified on27 October 2021


Yes No Not Sure

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 enrolled previously in the current study and been discontinued
Has invasive candidiasis (Part B)
Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
Has QTc prolongation at screening >500 msec
Has significant liver dysfunction
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