Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
Start Date
2/22/2022
Completion Date
12/31/2026
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 invasive fungal infection (IFI).
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 age and ≥5 who transition to the PFS formulation of POS.
Eligibility Criteria
Age Range: No minimum to 2 years
Interventions
Posaconazole IV 6 mg/kg
Posaconazole PFS 6 mg/kg
Conditions
Locations
Rady Children's Hospital-San Diego ( Site 2101)
San Diego, California 92123
United States
Nicklaus Children's Hospital ( Site 2109)
Miami, Florida 33155
United States
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago, Illinois 60611
United States
Duke University Medical Center ( Site 2106)
Durham, North Carolina 27710
United States
Driscoll Children's Hospital ( Site 2113)
Corpus Christi, Texas 78411
United States
UCL Saint Luc ( Site 1050)
Brussels, Bruxelles-Capitale, Region de 1200
Belgium
UZ Gent ( Site 1052)
Ghent, Oost-Vlaanderen 9000
Belgium
UZ Leuven ( Site 1051)
Leuven, Vlaams-Brabant 3000
Belgium
Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)
Athens, Attica 115 27
Greece
General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
Thessaloniki, 546 42
Greece
Rambam Medical Center ( Site 1402)
Haifa, 3109601
Israel
Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)
Jerusalem, 9112001
Israel
Sheba Medical Center ( Site 1404)
Ramat Gan, 5265601
Israel
Sourasky Medical Center ( Site 1403)
Tel Aviv, 6423906
Israel
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)
Mexico City, Mexico City 04530
Mexico
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)
Mexico City, Mexico City 06720
Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203)
Monterrey, Nuevo León 64460
Mexico
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)
Lima, 15038
Peru
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)
Wroclaw, Lower Silesian Voivodeship 50-556
Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)
Olsztyn, Warmian-Masurian Voivodeship 10-561
Poland
Mechnikov State Medical University ( Site 1803)
Saint Petersburg, Sankt-Peterburg 194291
Russia
Pavlov State Medical University ( Site 1801)
Saint Petersburg, Sankt-Peterburg 197022
Russia
Regional Children Clinical Hospital 1 ( Site 1802)
Yekaterinburg, Sverdlovsk Oblast 620149
Russia
Seoul National University Hospital-Pediatrics ( Site 2600)
Seoul, 03080
South Korea
Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76014
Ukraine
NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)
Kiev, Kyiv Oblast 01135
Ukraine