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

Description

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).

Conditions

Invasive Fungal Infection

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Invasive Fungal Infection
Intervention / Treatment

-

Contacts and Locations

San Diego

Rady Children's Hospital-San Diego ( Site 2101), San Diego, California, United States, 92123

Miami

Nicklaus Children's Hospital ( Site 2109), Miami, Florida, United States, 33155

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104), Chicago, Illinois, United States, 60611

Durham

Duke University Medical Center ( Site 2106), Durham, North Carolina, United States, 27710

Corpus Christi

Driscoll Children's Hospital ( Site 2113), Corpus Christi, Texas, United States, 78411

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

1 Day to 2 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2025-12-31