Actively Recruiting
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
Led by Merck Sharp & Dohme LLC · Updated on 2025-09-18
40
Participants Needed
26
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Panel A participants are receiving treatment for possible, probable, or proven invasive fungal infection caused by fungi treatable with posaconazole, including candidiasis
- Panel B participants have diagnosed possible, probable, or proven invasive fungal infection caused by fungi treatable with posaconazole, excluding candidiasis
- Participant has or will have a central line before starting intravenous treatment
- Participant weighs at least 500 grams
- Documented informed consent has been provided by the participant or guardian
You will not qualify if you...
- Received posaconazole within 30 days before starting the study
- Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
- Has hereditary problems with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Has known or suspected active COVID-19 infection
- Has serious allergy or reaction to azole antifungal drugs or study ingredients
- History of serious heart conditions or prolonged QT interval related to the heart
- Taken prohibited medications within specified timeframes before study
- Suspected or proven invasive candidiasis (Panel B)
- Previously enrolled and discontinued in this study
- QTc prolongation over 500 milliseconds at screening
- Significant liver dysfunction
- Hemodynamically unstable or not expected to survive at least 5 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Rady Children's Hospital-San Diego ( Site 2101)
San Diego, California, United States, 92123
Completed
2
Nicklaus Children's Hospital ( Site 2109)
Miami, Florida, United States, 33155
Completed
3
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Duke University Medical Center ( Site 2106)
Durham, North Carolina, United States, 27710
Completed
5
Driscoll Children's Hospital ( Site 2113)
Corpus Christi, Texas, United States, 78411
Completed
6
UCL Saint Luc ( Site 1050)
Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
Actively Recruiting
7
UZ Gent ( Site 1052)
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
8
UZ Leuven ( Site 1051)
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
9
Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)
Athens, Attica, Greece, 115 27
Completed
10
General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
Thessaloniki, Greece, 546 42
Actively Recruiting
11
Rambam Medical Center ( Site 1402)
Haifa, Israel, 3109601
Actively Recruiting
12
Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)
Jerusalem, Israel, 9112001
Completed
13
Sheba Medical Center ( Site 1404)
Ramat Gan, Israel, 5265601
Actively Recruiting
14
Sourasky Medical Center ( Site 1403)
Tel Aviv, Israel, 6423906
Actively Recruiting
15
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)
Mexico City, Mexico City, Mexico, 04530
Actively Recruiting
16
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)
Mexico City, Mexico City, Mexico, 06720
Actively Recruiting
17
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203)
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
18
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)
Lima, Peru, 15038
Actively Recruiting
19
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Actively Recruiting
20
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)
Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-561
Completed
21
Mechnikov State Medical University ( Site 1803)
Saint Petersburg, Sankt-Peterburg, Russia, 194291
Completed
22
Pavlov State Medical University ( Site 1801)
Saint Petersburg, Sankt-Peterburg, Russia, 197022
Completed
23
Regional Children Clinical Hospital 1 ( Site 1802)
Yekaterinburg, Sverdlovsk Oblast, Russia, 620149
Completed
24
Seoul National University Hospital-Pediatrics ( Site 2600)
Seoul, South Korea, 03080
Actively Recruiting
25
Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76014
Actively Recruiting
26
NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)
Kiev, Kyiv Oblast, Ukraine, 01135
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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