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

NCT04665037

RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Invasive Fungal Infection

Interventions: Posaconazole IV 6 mg/kg, Posaconazole PFS 6 mg/kg

Countries: United States, Belgium, Greece, Israel, Mexico, Peru, Poland, Russia

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).

Eligibility overview

Sex: ALL

Age: 1 Day to 2 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (26)
  • San Diego, California, United States
  • Miami, Florida, United States
  • Chicago, Illinois, United States
  • Durham, North Carolina, United States
  • Corpus Christi, Texas, United States
  • Brussels, Bruxelles-Capitale, Region de, Belgium
  • Ghent, Oost-Vlaanderen, Belgium
  • Leuven, Vlaams-Brabant, Belgium
  • Athens, Attica, Greece
  • Thessaloniki, Greece
  • Haifa, Israel
  • Jerusalem, Israel
  • Ramat Gan, Israel
  • Tel Aviv, Israel
  • Mexico City, Mexico City, Mexico
  • Mexico City, Mexico City, Mexico
  • Monterrey, Nuevo León, Mexico
  • Lima, Peru
  • Wroclaw, Lower Silesian Voivodeship, Poland
  • Olsztyn, Warmian-Masurian Voivodeship, Poland
  • Saint Petersburg, Sankt-Peterburg, Russia
  • Saint Petersburg, Sankt-Peterburg, Russia
  • Yekaterinburg, Sverdlovsk Oblast, Russia
  • Seoul, South Korea
  • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
  • Kiev, Kyiv Oblast, Ukraine