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

August 10, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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