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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-2
SponsorMerck Sharp & Dohme LLC

About this trial

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).

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Posaconazole IV 6 mg/kg
  • Posaconazole PFS 6 mg/kg

Treatment groups

40 Participants
are divided into 3 treatment groups

Sponsors and collaborators