Phase
Condition
Systemic Fungal Infections
Treatment
Posaconazole IV TBD
Posaconazole IV 6 mg/kg
Posaconazole PFS TBD
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
BelgiumActive - Recruiting
UZ Gent ( Site 1052)
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
UZ Leuven ( Site 1051)
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)
Athens, Attiki 115 27
GreeceActive - Recruiting
General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
Thessaloniki, 546 42
GreeceActive - Recruiting
Rambam Medical Center ( Site 1402)
Haifa, 3109601
IsraelActive - Recruiting
Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)
Jerusalem, 9112001
IsraelActive - Recruiting
Sheba Medical Center ( Site 1404)
Ramat Gan, 5265601
IsraelActive - Recruiting
Sourasky Medical Center ( Site 1403)
Tel Aviv, 6423906
IsraelActive - Recruiting
Seoul National University Hospital-Pediatrics ( Site 2600)
Seoul, 03080
Korea, Republic ofActive - Recruiting
Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)
Mexico City, Distrito Federal 06720
MexicoActive - Recruiting
Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)
Mexico City, Distrito Federal 04530
MexicoActive - Recruiting
Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)
Lima, 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
PolandActive - Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)
Olsztyn, Warminsko-mazurskie 10-561
PolandCompleted
Mechnikov State Medical University ( Site 1803)
Saint Petersburg, Sankt-Peterburg 194291
Russian FederationCompleted
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 FederationCompleted
Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)
Ivano-Frankivsk, Ivano-Frankivska Oblast 76014
UkraineActive - Recruiting
NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)
Kiev, Kyiv 01135
UkraineActive - Recruiting
Rady Children's Hospital-San Diego ( Site 2101)
San Diego, California 92123
United StatesCompleted
Nicklaus Children's Hospital ( Site 2109)
Miami, Florida 33155
United StatesCompleted
Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
Chicago, Illinois 60611
United StatesActive - Recruiting
Duke University Medical Center ( Site 2106)
Durham, North Carolina 27710
United StatesCompleted
Driscoll Children's Hospital ( Site 2113)
Corpus Christi, Texas 78411
United StatesCompleted
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