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NCT04665037PHASE2Recruiting

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

Merck Sharp & Dohme LLC

Start Date

2/22/2022

Completion Date

12/31/2026

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).

Detailed Description

There are 2 panels in this study. In Panel A, POS IV will be evaluated in ≥8 participants. In Panel B, both POS IV and POS PFS will be evaluated in ≥14 participants, including ≥6 who are \<3 months of age and ≥5 who transition to the PFS formulation of POS.

Eligibility Criteria

Age Range: No minimum to 2 years

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

Interventions

DRUG

Posaconazole IV 6 mg/kg

DRUG

Posaconazole PFS 6 mg/kg

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Conditions

Invasive Fungal Infection

Locations

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

San Diego, California 92123

United States

Nicklaus Children's Hospital ( Site 2109)

Miami, Florida 33155

United States

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

Chicago, Illinois 60611

United States

Duke University Medical Center ( Site 2106)

Durham, North Carolina 27710

United States

Driscoll Children's Hospital ( Site 2113)

Corpus Christi, Texas 78411

United States

UCL Saint Luc ( Site 1050)

Brussels, Bruxelles-Capitale, Region de 1200

Belgium

UZ Gent ( Site 1052)

Ghent, Oost-Vlaanderen 9000

Belgium

UZ Leuven ( Site 1051)

Leuven, Vlaams-Brabant 3000

Belgium

Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)

Athens, Attica 115 27

Greece

General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)

Thessaloniki, 546 42

Greece

Rambam Medical Center ( Site 1402)

Haifa, 3109601

Israel

Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)

Jerusalem, 9112001

Israel

Sheba Medical Center ( Site 1404)

Ramat Gan, 5265601

Israel

Sourasky Medical Center ( Site 1403)

Tel Aviv, 6423906

Israel

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

Mexico City, Mexico City 04530

Mexico

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

Mexico City, Mexico City 06720

Mexico

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

Monterrey, Nuevo León 64460

Mexico

Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)

Lima, 15038

Peru

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

Wroclaw, Lower Silesian Voivodeship 50-556

Poland

Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)

Olsztyn, Warmian-Masurian Voivodeship 10-561

Poland

Mechnikov State Medical University ( Site 1803)

Saint Petersburg, Sankt-Peterburg 194291

Russia

Pavlov State Medical University ( Site 1801)

Saint Petersburg, Sankt-Peterburg 197022

Russia

Regional Children Clinical Hospital 1 ( Site 1802)

Yekaterinburg, Sverdlovsk Oblast 620149

Russia

Seoul National University Hospital-Pediatrics ( Site 2600)

Seoul, 03080

South Korea

Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)

Ivano-Frankivsk, Ivano-Frankivsk Oblast 76014

Ukraine

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

Kiev, Kyiv Oblast 01135

Ukraine