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

September 17, 2025 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
    • Bruxelles-Capitale, Region de
      • Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
        • Recruiting
        • UCL Saint Luc ( Site 1050)
        • Contact:
          • Study Coordinator
          • Phone Number: +3227646086
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 1052)
        • Contact:
          • Study Coordinator
          • Phone Number: +3293324986
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • UZ Leuven ( Site 1051)
        • Contact:
          • Study Coordinator
          • Phone Number: +3216343972
  • Greece
      • Thessaloniki, Greece, 546 42
        • Recruiting
        • General Hospital of Thessaloniki "Ippokrateio" ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: 306937442644
    • Attica
      • Athens, Attica, Greece, 115 27
        • Completed
        • Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Medical Center ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247774512
      • Jerusalem, Israel, 9112001
        • Completed
        • Hadassah Ein Karem Hebrew University Medical Center ( Site 1401)
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235305046
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: +97236974521
  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 04530
        • Recruiting
        • Instituto Nacional de Pediatria-Unidad de Apoyo a la Investigación Clínica ( Site 2200)
        • Contact:
          • Study Coordinator
          • Phone Number: 5525600809
      • Mexico City, Mexico City, Mexico, 06720
        • Recruiting
        • Hospital Infantil de Mexico Federico Gomez-Infectious Diseases ( Site 2202)
        • Contact:
          • Study Coordinator
          • Phone Number: 525539391946
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Infectologia ( Site 2203)
        • Contact:
          • Study Coordinator
          • Phone Number: (+52) 8183486173
  • Peru
      • Lima, Peru, 15038
        • Recruiting
        • Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: +5112016500
  • Poland
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Transplantacji Szpiku, Onkolog ( Site 1708)
        • Contact:
          • Study Coordinator
          • Phone Number: 48717332700
    • Warmian-Masurian Voivodeship
      • Olsztyn, Warmian-Masurian Voivodeship, Poland, 10-561
        • Completed
        • Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)
  • Russia
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 194291
        • Completed
        • Mechnikov State Medical University ( Site 1803)
      • Saint Petersburg, Sankt-Peterburg, Russia, 197022
        • Completed
        • Pavlov State Medical University ( Site 1801)
    • Sverdlovsk Oblast
      • Yekaterinburg, Sverdlovsk Oblast, Russia, 620149
        • Completed
        • Regional Children Clinical Hospital 1 ( Site 1802)
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital-Pediatrics ( Site 2600)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220723452
  • Ukraine
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76014
        • Recruiting
        • Ivano-Frankivsk Regional Pediatric Clinical Hospital ( Site 1911)
        • Contact:
          • Study Coordinator
          • Phone Number: +380971550299
    • Kyiv Oblast
      • Kiev, Kyiv Oblast, Ukraine, 01135
        • Recruiting
        • NATIONAL CHILDREN'S SPECIALIZED HOSPITAL "OKHMATDYT" OF THE -Intensive Care Unit ( Site 1912)
        • Contact:
          • Study Coordinator
          • Phone Number: +380685949474
  • United States
    • California
      • San Diego, California, United States, 92123
        • Completed
        • Rady Children's Hospital-San Diego ( Site 2101)
    • Florida
      • Miami, Florida, United States, 33155
        • Completed
        • Nicklaus Children's Hospital ( Site 2109)
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann & Robert H. Lurie Children's Hospital of Chicago ( Site 2104)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-227-6280
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Completed
        • Duke University Medical Center ( Site 2106)
    • Texas
      • Corpus Christi, Texas, United States, 78411
        • Completed
        • Driscoll Children's Hospital ( Site 2113)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panel A: POS IV
Posaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1.
Drug: Posaconazole IV 6 mg/kg
POS 6 mg/kg body weight by IV infusion
Other Names:
  • NOXAFIL®
  • MK-5592
  • SCH56592
Experimental: Panel B: POS IV
Posaconazole 6 mg/kg body weight administered twice daily by IV infusion on Day 1, and then once daily from Day 2 to a maximum 84 days.
Drug: Posaconazole IV 6 mg/kg
POS 6 mg/kg body weight by IV infusion
Other Names:
  • NOXAFIL®
  • MK-5592
  • SCH56592
Experimental: Panel B: POS PFS
Following a minimum of 7 days IV dosing, participants as clinically able will be transitioned from POS IV to POS PFS nominal 6 mg/kg body weight based on weight bands administered on Day 8, once daily to a maximum 84 days.
Drug: Posaconazole PFS 6 mg/kg
POS nominal 6 mg/kg body weight based on weight bands taken orally
Other Names:
  • NOXAFIL®
  • MK-5592
  • SCH56592

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average concentration (Cavg) of single-dose IV POS (Panel A)
Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1
The Cavg of IV POS is based on population PK analysis.
Predose, 0.25 and 24 hours post-infusion on Day 1
Maximum concentration (Cmax) of single-dose IV POS (Panel A)
Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1
The Cmax of IV POS is based on population PK analysis.
Predose, 0.25 and 24 hours post-infusion on Day 1
Time to maximum concentration (Tmax) of single-dose IV POS (Panel A)
Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1
The Tmax of IV POS is based on population PK analysis.
Predose, 0.25 and 24 hours post-infusion on Day 1
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A)
Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1
The AUC 0-24 of IV POS is based on population PK analysis.
Predose, 0.25 and 24 hours post-infusion on Day 1
Clearance (CL) of single-dose IV POS (Panel A)
Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1
The clearance (CL) of IV POS is based on population PK analysis.
Predose, 0.25 and 24 hours post-infusion on Day 1
Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A)
Time Frame: Predose, 0.25 and 24 hours post-infusion on Day 1
The AUC0-∞ of IV POS is based on population PK analysis.
Predose, 0.25 and 24 hours post-infusion on Day 1
Cavg of multiple-dose IV POS (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cavg of IV POS is based on population PK analysis.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
Cmax of multiple-dose IV POS (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cmax of IV POS is based on population PK analysis.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
Tmax of multiple-dose IV POS (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Tmax of IV POS is based on population PK analysis.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
AUC0-24 of multiple-dose IV POS (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The AUC0-24 of IV POS is based on population PK analysis.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
Cavg of multiple-dose PFS POS (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cavg of PFS POS is based on population PK analysis.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
Cmax of multiple-dose PFS POS (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cmax of PFS POS is based on population PK analysis.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
AUC0-24 of multiple-dose PFSPOS (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The AUC0-24 of PFS POS is based on population PK analysis.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
CL of multiple-dose IV POS (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The CL of IV POS is based on population PK analysis.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B)
Time Frame: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
The Cavg of IV POS is based on population PK analysis. Comparisons between participants in Panel B will be made to data that was previously collected in older participants.
Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12
Percentage of participants with all-cause mortality (ACM) [Panel B]
Time Frame: Up to 28 days
The percentage of participants with ACM will be reported.
Up to 28 days
Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period (Panel B)
Time Frame: Up to 84 days
Percentage of participants who received additional antifungal therapy in Panel B will be reported.
Up to 84 days
Percentage of participants with an ≥ 1 adverse event (AE) [Panels A and B]
Time Frame: Up to 98 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to 98 days
Percentage of participants who discontinued study therapy due to an AE (Panels A and B)
Time Frame: Up to 84 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to 84 days
Percentage of participants with a drug-related AE (Panels A and B)
Time Frame: Up to 98 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Up to 98 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2022

Primary Completion (Estimated)

December 16, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 9, 2020

First Submitted That Met QC Criteria

December 9, 2020

First Posted (Actual)

December 11, 2020

Study Record Updates

Last Update Posted (Estimated)

September 18, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5592-127
  • MK-5592-127 (Other Identifier: MSD)
  • 2019-003842-34 (EudraCT Number)
  • PHRR230411-005589 (Registry Identifier: PHRR)
  • U1111-1292-1190 (Registry Identifier: UTN)
  • 2023-505613-24-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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