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

Last updated: May 14, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Systemic Fungal Infections

Treatment

Posaconazole IV TBD

Posaconazole IV 6 mg/kg

Posaconazole PFS TBD

Clinical Study ID

NCT04665037
5592-127
MK-5592-127
2019-003842-34
U1111-1292-1190
PHRR230411-005589
2023-505613-24
2023-505613-24-00
  • Ages 1-2
  • All Genders

Study 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).

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

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Posaconazole IV TBD
Phase: 2
Study Start date:
February 22, 2022
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • UCL Saint Luc ( Site 1050)

    Brussels, Bruxelles-Capitale, Region De 1200
    Belgium

    Active - Recruiting

  • UZ Gent ( Site 1052)

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • UZ Leuven ( Site 1051)

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)

    Athens, Attiki 115 27
    Greece

    Active - Recruiting

  • General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)

    Thessaloniki, 546 42
    Greece

    Active - Recruiting

  • Rambam Medical Center ( Site 1402)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • Sheba Medical Center ( Site 1404)

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Sourasky Medical Center ( Site 1403)

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • Seoul National University Hospital-Pediatrics ( Site 2600)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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

    Mexico City, Distrito Federal 06720
    Mexico

    Active - Recruiting

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

    Mexico City, Distrito Federal 04530
    Mexico

    Active - Recruiting

  • Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)

    Lima, 15038
    Peru

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog

    Wrocław, Dolnoslaskie 50-556
    Poland

    Active - Recruiting

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

    Wrocław, Dolnoslaskie 50-556
    Poland

    Active - Recruiting

  • Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)

    Olsztyn, Warminsko-mazurskie 10-561
    Poland

    Completed

  • Mechnikov State Medical University ( Site 1803)

    Saint Petersburg, Sankt-Peterburg 194291
    Russian Federation

    Completed

  • Pavlov State Medical University ( Site 1801)

    Saint Petersburg, Sankt-Peterburg 197022
    Russian Federation

    Completed

  • Regional Children Clinical Hospital 1 ( Site 1802)

    Ekaterinburg, Sverdlovskaya Oblast 620149
    Russian Federation

    Completed

  • Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)

    Ivano-Frankivsk, Ivano-Frankivska Oblast 76014
    Ukraine

    Active - Recruiting

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

    Kiev, Kyiv 01135
    Ukraine

    Active - Recruiting

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

    San Diego, California 92123
    United States

    Completed

  • Nicklaus Children's Hospital ( Site 2109)

    Miami, Florida 33155
    United States

    Completed

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

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Duke University Medical Center ( Site 2106)

    Durham, North Carolina 27710
    United States

    Completed

  • Driscoll Children's Hospital ( Site 2113)

    Corpus Christi, Texas 78411
    United States

    Completed

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