Loading clinical trials...

Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT04665037•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).

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

Age

0 - 2 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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

Key Dates

Start Date

February 22, 2022

Primary Completion Date

December 16, 2026

Completion Date

December 31, 2026

Last Updated

September 18, 2025

Enrollment

ESTIMATED participants

Conditions

Invasive Fungal Infection

Interventions

Posaconazole IV 6 mg/kg

DRUG

Posaconazole PFS 6 mg/kg

DRUG

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

NCT06105411

Invasive Fungal Infections

View study

RECRUITING

Breath Analysis for the Detection of Invasive Fungal Infections

NCT06537726

LeukemiaLeukemia, Myeloid+5 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Siderophore-labelled Positron Emission Tomography for Correlating Invasive Fungal InfeCtions

Breath Analysis for the Detection of Invasive Fungal Infections

Usefulness of PET-CT for Invasive Fungal Infection

L-AmB_ Retrospective mUlticenter Study on Mycosis prOphylaxis

Hyperbaric Oxygen Therapy Used on Severely Injured Healthy Individuals With Fungal Infections

Human Bioequivalence Study of Amphotericin B Liposome for Injection