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Invasive Fungal InfectionPhase 2NCT04665037

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

A Phase 2 study testing Posaconazole IV 6 mg/kg and Posaconazole PFS 6 mg/kg in people with Invasive Fungal Infection, run by Merck Sharp & Dohme LLC at 26 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 1 day to 2 years
Conditions the study is for
Invasive Fungal Infection
What is being tested?
Posaconazole IV 6 mg/kg and Posaconazole PFS 6 mg/kg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
26 sitesin 10 countries
Study dates
22 Feb 2022to 15 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 2 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

26 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

26 sites in 10 countries

United States5 sites, 1 recruiting

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

    Chicago, Illinois, 60611

    Study Coordinator, 312-227-6280

    Recruiting

  • Driscoll Children's Hospital ( Site 2113)

    Corpus Christi, Texas, 78411

    Completed

  • Duke University Medical Center ( Site 2106)

    Durham, North Carolina, 27710

    Completed

  • Nicklaus Children's Hospital ( Site 2109)

    Miami, Florida, 33155

    Completed

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

    San Diego, California, 92123

    Completed

Other trials in United States

Israel4 sites, 3 recruiting

  • Rambam Medical Center ( Site 1402)

    Haifa, 3109601

    Study Coordinator, +97247774512

    Recruiting

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

    Jerusalem, 9112001

    Completed

  • Sheba Medical Center ( Site 1404)

    Ramat Gan, 5265601

    Study Coordinator, +97235305046

    Recruiting

  • Sourasky Medical Center ( Site 1403)

    Tel Aviv, 6423906

    Study Coordinator, +97236974521

    Recruiting

Other trials in Israel

Belgium3 sites, 3 recruiting

  • UCL Saint Luc ( Site 1050)

    Brussels, Bruxelles-Capitale, Region de, 1200

    Study Coordinator, +3227646086

    Recruiting

  • UZ Gent ( Site 1052)

    Ghent, Oost-Vlaanderen, 9000

    Study Coordinator, +3293324986

    Recruiting

  • UZ Leuven ( Site 1051)

    Leuven, Vlaams-Brabant, 3000

    Study Coordinator, +3216343972

    Recruiting

Other trials in Belgium

Mexico3 sites, 3 recruiting

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

    Mexico City, Mexico City, 04530

    Study Coordinator, 5525600809

    Recruiting

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

    Mexico City, Mexico City, 06720

    Study Coordinator, 525539391946

    Recruiting

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

    Monterrey, Nuevo León, 64460

    Study Coordinator, (+52) 8183486173

    Recruiting

Other trials in Mexico

Russia3 sites

  • Mechnikov State Medical University ( Site 1803)

    Saint Petersburg, Sankt-Peterburg, 194291

    Completed

  • Pavlov State Medical University ( Site 1801)

    Saint Petersburg, Sankt-Peterburg, 197022

    Completed

  • Regional Children Clinical Hospital 1 ( Site 1802)

    Yekaterinburg, Sverdlovsk Oblast, 620149

    Completed

Other trials in Russia

Greece2 sites, 1 recruiting

  • Athens Childrens Hospital Aglaia Kyriakou ( Site 1102)

    Athens, Attica, 115 27

    Completed

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

    Thessaloniki, 546 42

    Study Coordinator, 306937442644

    Recruiting

Other trials in Greece

Poland2 sites, 1 recruiting

  • Wojewodzki Specjalistyczny Szpital Dzieciecy ( Site 1705)

    Olsztyn, Warmian-Masurian Voivodeship, 10-561

    Completed

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

    Wroclaw, Lower Silesian Voivodeship, 50-556

    Study Coordinator, 48717332700

    Recruiting

Other trials in Poland

Ukraine2 sites, 2 recruiting

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

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76014

    Study Coordinator, +380971550299

    Recruiting

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

    Kiev, Kyiv Oblast, 01135

    Study Coordinator, +380685949474

    Recruiting

Other trials in Ukraine

Peru1 site, 1 recruiting

  • Instituto Nacional de Enfermedades Neoplasicas ( Site 1601)

    Lima, 15038

    Study Coordinator, +5112016500

    Recruiting

Other trials in Peru

South Korea1 site, 1 recruiting

  • Seoul National University Hospital-Pediatrics ( Site 2600)

    Seoul, 03080

    Study Coordinator, +82220723452

    Recruiting

Other trials in South Korea

About this study

Official title: 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).

Read the 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.

Being tested
Posaconazole IV 6 mg/kg, Posaconazole PFS 6 mg/kg
Medical subject headings
Invasive Fungal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Posaconazole IV 6 mg/kgDrug

    Also called MK-5592, NOXAFIL®, SCH56592

    POS 6 mg/kg body weight by IV infusion

  • Posaconazole PFS 6 mg/kgDrug

    Also called MK-5592, NOXAFIL®, SCH56592

    POS nominal 6 mg/kg body weight based on weight bands taken orally

Study groups in NCT04665037
Study groupRoleWhat they receive
Panel A: POS IVExperimentalPosaconazole 6 mg/kg body weight administered in a single dose by IV infusion on Day 1.
Receives: Drug: Posaconazole IV 6 mg/kg
Panel B: POS IVExperimentalPosaconazole 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.
Receives: Drug: Posaconazole IV 6 mg/kg
Panel B: POS PFSExperimentalFollowing 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.
Receives: Drug: Posaconazole PFS 6 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average concentration (Cavg) of single-dose IV POS (Panel A)

    The Cavg of IV POS is based on population PK analysis.

    Measured: Predose, 0.25 and 24 hours post-infusion on Day 1

  2. Maximum concentration (Cmax) of single-dose IV POS (Panel A)

    The Cmax of IV POS is based on population PK analysis.

    Measured: Predose, 0.25 and 24 hours post-infusion on Day 1

  3. Time to maximum concentration (Tmax) of single-dose IV POS (Panel A)

    The Tmax of IV POS is based on population PK analysis.

    Measured: Predose, 0.25 and 24 hours post-infusion on Day 1

  4. Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of single-dose IV POS (Panel A)

    The AUC 0-24 of IV POS is based on population PK analysis.

    Measured: Predose, 0.25 and 24 hours post-infusion on Day 1

  5. Clearance (CL) of single-dose IV POS (Panel A)

    The clearance (CL) of IV POS is based on population PK analysis.

    Measured: Predose, 0.25 and 24 hours post-infusion on Day 1

  6. Area under the plasma concentration-time curve from dosing to infinity (AUC0-∞) of single-dose IV POS (Panel A)

    The AUC0-∞ of IV POS is based on population PK analysis.

    Measured: Predose, 0.25 and 24 hours post-infusion on Day 1

  7. Cavg of multiple-dose IV POS (Panel B)

    The Cavg of IV POS is based on population PK analysis.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

  8. Cmax of multiple-dose IV POS (Panel B)

    The Cmax of IV POS is based on population PK analysis.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

  9. Tmax of multiple-dose IV POS (Panel B)

    The Tmax of IV POS is based on population PK analysis.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

  10. AUC0-24 of multiple-dose IV POS (Panel B)

    The AUC0-24 of IV POS is based on population PK analysis.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

  11. CL of multiple-dose IV POS (Panel B)

    The CL of IV POS is based on population PK analysis.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

  12. Cavg of multiple-dose PFS POS (Panel B)

    The Cavg of PFS POS is based on population PK analysis.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

  13. Cmax of multiple-dose PFS POS (Panel B)

    The Cmax of PFS POS is based on population PK analysis.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

  14. AUC0-24 of multiple-dose PFSPOS (Panel B)

    The AUC0-24 of PFS POS is based on population PK analysis.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

Secondary outcomes (6)

  1. Cavg of IV POS in neonates and infants <2 years of age compared to adults and older pediatric populations (Panel B)

    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.

    Measured: Predose and 0.25 post-infusion on Day 1; Weeks 1, 2, 4, 6, 9, and 12

  2. Percentage of participants with an ≥ 1 adverse event (AE) [Panels A and B]

    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.

    Measured: Up to 98 days

  3. Percentage of participants who discontinued study therapy due to an AE (Panels A and B)

    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.

    Measured: Up to 84 days

  4. Percentage of participants with a drug-related AE (Panels A and B)

    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.

    Measured: Up to 98 days

  5. Percentage of participants with all-cause mortality (ACM) [Panel B]

    The percentage of participants with ACM will be reported.

    Measured: Up to 28 days

  6. Percentage of participants with need for systemic antifungal therapy (other than POS) during the study period (Panel B)

    Percentage of participants who received additional antifungal therapy in Panel B will be reported.

    Measured: Up to 84 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start22 Feb 2022
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion15 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04665037
Sponsor's protocol ID
5592-127
Other IDs
MK-5592-127, PHRR230411-005589, 2023-505613-24-00, U1111-1292-1190, 2019-003842-34, 2019, 2023
Status last verified
Jul 2026
First submitted
9 Dec 2020
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Posaconazole IV 6 mg/kg and Posaconazole PFS 6 mg/kg in people with Invasive Fungal Infection, run by Merck Sharp & Dohme LLC at 26 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Israel, Belgium, Mexico, Russia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average concentration (Cavg) of single-dose IV POS (Panel A) (time frame: Predose, 0.25 and 24 hours post-infusion on Day 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04665037.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.

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