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RECRUITING

NCT04665037

PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

Official title: A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection

Key Details

Gender

All

Age Range

1 Day - 2 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-02-22

Completion Date

2026-12-31

Last Updated

2025-09-18

Healthy Volunteers

Conditions

Invasive Fungal Infection

Interventions

DRUG

Posaconazole IV 6 mg/kg

POS 6 mg/kg body weight by IV infusion

DRUG

Posaconazole PFS 6 mg/kg

POS nominal 6 mg/kg body weight based on weight bands taken orally

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)

Rady Children's Hospital-San Diego ( Site 2101)

San Diego, California, United States

Nicklaus Children's Hospital ( Site 2109)

Miami, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)

Chicago, Illinois, United States

Duke University Medical Center ( Site 2106)

Durham, North Carolina, United States

Driscoll Children's Hospital ( Site 2113)

Corpus Christi, Texas, United States

UCL Saint Luc ( Site 1050)

Brussels, Bruxelles-Capitale, Region de, Belgium

UZ Gent ( Site 1052)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 1051)

Leuven, Vlaams-Brabant, Belgium

Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)

Athens, Attica, Greece

General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)

Thessaloniki, Greece

Rambam Medical Center ( Site 1402)

Haifa, Israel

Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)

Jerusalem, Israel

Sheba Medical Center ( Site 1404)

Ramat Gan, Israel

Sourasky Medical Center ( Site 1403)

Tel Aviv, Israel

Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)

Mexico City, Mexico City, Mexico

Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)

Mexico City, Mexico City, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203)

Monterrey, Nuevo León, Mexico

Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)

Lima, Peru

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)

Wroclaw, Lower Silesian Voivodeship, Poland

Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)

Olsztyn, Warmian-Masurian Voivodeship, Poland

Mechnikov State Medical University ( Site 1803)

Saint Petersburg, Sankt-Peterburg, Russia

Pavlov State Medical University ( Site 1801)

Saint Petersburg, Sankt-Peterburg, Russia

Regional Children Clinical Hospital 1 ( Site 1802)

Yekaterinburg, Sverdlovsk Oblast, Russia

Seoul National University Hospital-Pediatrics ( Site 2600)

Seoul, South Korea

Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)

Kiev, Kyiv Oblast, Ukraine