Status:
RECRUITING
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Invasive Fungal Infection
Eligibility:
All Genders
1-2 years
Phase:
PHASE2
Brief 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 ...
Detailed Description
There are 2 panels in this study. In Panel A, POS IV will be evaluated in ≥8 participants. In Panel B, both POS IV and POS PFS will be evaluated in ≥14 participants, including ≥6 who are \<3 months of...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04665037
Start Date
February 22 2022
End Date
December 31 2026
Last Update
September 18 2025
Active Locations (26)
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1
Rady Children's Hospital-San Diego ( Site 2101)
San Diego, California, United States, 92123
2
Nicklaus Children's Hospital ( Site 2109)
Miami, Florida, United States, 33155
3
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago, Illinois, United States, 60611
4
Duke University Medical Center ( Site 2106)
Durham, North Carolina, United States, 27710