Phase
Condition
Systemic Fungal Infections
Treatment
Posaconazole PFS TBD
Posaconazole IV TBD
Posaconazole IV 6 mg/kg
Clinical Study ID
Ages 1-2 All Genders
Study Summary
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
Study Design
Study Description
Connect with a study center
UCL Saint Luc ( Site 1050)
Brussels, Bruxelles-Capitale, Region De 1200
BelgiumSite Not Available
UCL Saint Luc ( Site 1050)
Brussels 2800866, Bruxelles-Capitale, Region de 1200
BelgiumActive - Recruiting
UZ Gent ( Site 1052)
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent ( Site 1052)
Ghent 2797656, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
UZ Leuven ( Site 1051)
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
UZ Leuven ( Site 1051)
Leuven 2792482, Vlaams-Brabant 3000
BelgiumActive - Recruiting
Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)
Athens 264371, Attica 6692632 115 27
GreeceCompleted
Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)
Athens, Attiki 115 27
GreeceSite Not Available
General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
Thessaloniki, 546 42
GreeceSite Not Available
General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
Thessaloniki 734077, 546 42
GreeceActive - Recruiting
Rambam Medical Center ( Site 1402)
Haifa, 3109601
IsraelSite Not Available
Rambam Medical Center ( Site 1402)
Haifa 294801, 3109601
IsraelActive - Recruiting
Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)
Jerusalem, 9112001
IsraelSite Not Available
Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)
Jerusalem 281184, 9112001
IsraelCompleted
Sheba Medical Center ( Site 1404)
Ramat Gan, 5265601
IsraelSite Not Available
Sheba Medical Center ( Site 1404)
Ramat Gan 293788, 5265601
IsraelActive - Recruiting
Sourasky Medical Center ( Site 1403)
Tel Aviv, 6423906
IsraelSite Not Available
Sourasky Medical Center ( Site 1403)
Tel Aviv 293397, 6423906
IsraelActive - Recruiting
Seoul National University Hospital-Pediatrics ( Site 2600)
Seoul, 03080
Korea, Republic ofSite Not Available
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)
Mexico City, Distrito Federal 06720
MexicoSite Not Available
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)
Mexico City, Distrito Federal 04530
MexicoActive - Recruiting
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)
Mexico City 3530597, Mexico City 3527646 06720
MexicoActive - Recruiting
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)
Mexico City 3530597, Mexico City 3527646 04530
MexicoActive - Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203)
Monterrey 3995465, Nuevo León 3522542 64460
MexicoActive - Recruiting
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)
Lima, 15038
PeruSite Not Available
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)
Lima 3936456, 15038
PeruActive - Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog
Wrocław, Dolnoslaskie 50-556
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)
Wrocław, Dolnoslaskie 50-556
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)
Wroclaw 3081368, Lower Silesian Voivodeship 3337492 50-556
PolandActive - Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)
Olsztyn 763166, Warmian-Masurian Voivodeship 858791 10-561
PolandCompleted
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)
Olsztyn, Warminsko-mazurskie 10-561
PolandSite Not Available
Mechnikov State Medical University ( Site 1803)
Saint Petersburg 498817, Sankt-Peterburg 536203 194291
RussiaCompleted
Pavlov State Medical University ( Site 1801)
Saint Petersburg 498817, Sankt-Peterburg 536203 197022
RussiaCompleted
Regional Children Clinical Hospital 1 ( Site 1802)
Yekaterinburg 1486209, Sverdlovsk Oblast 1490542 620149
RussiaCompleted
Mechnikov State Medical University ( Site 1803)
Saint Petersburg, Sankt-Peterburg 194291
Russian FederationSite Not Available
Pavlov State Medical University ( Site 1801)
Saint Petersburg, Sankt-Peterburg 197022
Russian FederationCompleted
Regional Children Clinical Hospital 1 ( Site 1802)
Ekaterinburg, Sverdlovskaya Oblast 620149
Russian FederationSite Not Available
Seoul National University Hospital-Pediatrics ( Site 2600)
Seoul 1835848, 03080
South KoreaActive - Recruiting
Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)
Ivano-Frankivsk 707471, Ivano-Frankivsk Oblast 707470 76014
UkraineActive - Recruiting
Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)
Ivano-Frankivsk, Ivano-Frankivska Oblast 76014
UkraineSite Not Available
NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)
Kiev, Kyiv Oblast 703446 01135
UkraineActive - Recruiting
Rady Children's Hospital-San Diego ( Site 2101)
San Diego, California 92123
United StatesSite Not Available
Rady Children's Hospital-San Diego ( Site 2101)
San Diego 5391811, California 5332921 92123
United StatesCompleted
Nicklaus Children's Hospital ( Site 2109)
Miami, Florida 33155
United StatesSite Not Available
Nicklaus Children's Hospital ( Site 2109)
Miami 4164138, Florida 4155751 33155
United StatesCompleted
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago, Illinois 60611
United StatesSite Not Available
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago 4887398, Illinois 4896861 60611
United StatesActive - Recruiting
Duke University Medical Center ( Site 2106)
Durham, North Carolina 27710
United StatesSite Not Available
Duke University Medical Center ( Site 2106)
Durham 4464368, North Carolina 4482348 27710
United StatesCompleted
Driscoll Children's Hospital ( Site 2113)
Corpus Christi, Texas 78411
United StatesSite Not Available
Driscoll Children's Hospital ( Site 2113)
Corpus Christi 4683416, Texas 4736286 78411
United StatesCompleted

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