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

Recruiting now · Phase 2

Conditions studied: Invasive Fungal Infection

In brief

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).

Key facts

Study ID

NCT04665037

Run by

Merck Sharp & Dohme LLC

People needed

40

Starts

2022-02-22

Expected to finish

2026-12-31

Last updated by the study team

2025-09-18

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912) — Kiev, Kyiv Oblast, Ukraine (enrolling)
• Rambam Medical Center ( Site 1402) — Haifa, Israel (enrolling)
• Sheba Medical Center ( Site 1404) — Ramat Gan, Israel (enrolling)
• Sourasky Medical Center ( Site 1403) — Tel Aviv, Israel (enrolling)
• Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200) — Mexico City, Mexico City, Mexico (enrolling)
• Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202) — Mexico City, Mexico City, Mexico (enrolling)
• Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203) — Monterrey, Nuevo León, Mexico (enrolling)
• Instituto Nacional de Enfermedades Neoplasicas ( Site 1601) — Lima, Peru (enrolling)
• Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708) — Wroclaw, Lower Silesian Voivodeship, Poland (enrolling)
• Seoul National University Hospital-Pediatrics ( Site 2600) — Seoul, South Korea (enrolling)
• Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911) — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104) — Chicago, Illinois, United States (enrolling)
• UCL Saint Luc ( Site 1050) — Brussels, Bruxelles-Capitale, Region de, Belgium (enrolling)
• UZ Gent ( Site 1052) — Ghent, Oost-Vlaanderen, Belgium (enrolling)
• UZ Leuven ( Site 1051) — Leuven, Vlaams-Brabant, Belgium (enrolling)
• General Hospital of Thessaloniki "Ippokrateio" ( Site 1100) — Thessaloniki, Greece (enrolling)
• Nicklaus Children's Hospital ( Site 2109) — Miami, Florida, United States
• Hadassah Ein Karem Hebrew University Medical Center ( Site 1401) — Jerusalem, Israel
• Duke University Medical Center ( Site 2106) — Durham, North Carolina, United States
• Driscoll Children's Hospital ( Site 2113) — Corpus Christi, Texas, United States
• Regional Children Clinical Hospital 1 ( Site 1802) — Yekaterinburg, Sverdlovsk Oblast, Russia
• Rady Children's Hospital-San Diego ( Site 2101) — San Diego, California, United States
• Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705) — Olsztyn, Warmian-Masurian Voivodeship, Poland
• Athens Childrens Hospital Aglaia Kyriakou ( Site 1102) — Athens, Attica, Greece
• Mechnikov State Medical University ( Site 1803) — Saint Petersburg, Sankt-Peterburg, Russia

Full record on ClinicalTrials.gov

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